Contribuição da ecoendoscopia com punção no diagnóstico dos

Transcription

RICARDO LEITE GANC
tumores sólidos do pâncreas.
Tese apresentada ao Curso de Pós
Graduação de Pesquisa em Cirurgia da
Faculdade de Ciências Médicas da Santa
Casa de São Paulo para obtenção do Titulo
de Doutor em Pesquisa em Cirurgia.
SÃO PAULO
2015
RICARDO LEITE GANC
tumores sólidos do pâncreas.
Tese apresentada ao Curso de Pós
Graduação de Pesquisa em Cirurgia da
Faculdade de Ciências Médicas da Santa
Casa de São Paulo para obtenção do Titulo
de Doutor em Pesquisa em Cirurgia.
Área de Concentração: Reparação Tecidual.
Orientador: Prof. Dr. Adhemar Monteiro Pacheco Jr.
SÃO PAULO
2015
FICHA CATALOGRÁFICA
Preparada pela Biblioteca Central da
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Ganc, Ricardo Leite
tumores sólidos do pâncreas./ Ricardo Leite Ganc. São Paulo, 2015.
Tese de Doutorado. Faculdade de Ciências Médicas da Santa
Casa de São Paulo – Curso de Pós-Graduação em Pesquisa em
Cirurgia.
Área de Concentração: Reparação Tecidual
Orientador: Adhemar Monteiro Pacheco Jr
1. Neoplasias pancreáticas 2. Endossonografia 3. Diagnóstico 4.
Aspiração por agulha fina guiada por ultrassom endoscópico
BC-FCMSCSP/78-15
Aos meus pais, Lídice e Arnaldo,
Por me cederem os ombros para que eu pudesse enxergar mais longe.
Às minha irmãs Renée e Alessandra,
Pelo carinho e força nos momentos mais difíceis e pelo sorriso nos momentos de alegria.
À minha esposa Vanessa,
Por estar presente e me apoiar em todos os momentos; pela paciência e pelo amor
dispendido em todas as horas.
Aos meus filhos Eduardo e Laura,
Por trazerem um novo significado à minha vida e por me ensinarem a amar
incondicionalmente
Aos meus Sogros e novos pais, Ondina e Américo
Por me receberem e me amarem como a um novo filho
“Se o autor não se emociona com a sua
própria criação, dificilmente pode esperar que outros o façam.”
Charles Chaplin
“A imaginação é mais importante que o
conhecimento. O conhecimento é limitado. A imaginação envolve o mundo.”
Albert Einstein
“Questionamento constante e freqüente é a
primeira chave para a sabedoria… Através do duvidar que somos levados a inquirir, e pelo
inquérito nós percebemos a verdade.”
Pedro Abelardo
AGRADECIMENTOS:
À Irmandade Santa Casa de Misericórdia de São Paulo e à sua Faculdade de Ciências
Médicas pela minha carreira acadêmica.
À Faculdade de Ciências Médicas da Santa Casa de São Paulo, pela qual me graduei como
médico em sua XXX turma e realizei minha pós-graduação em cirurgia
Ao Professor Doutor Luis Arnaldo Szutan, professor e conselheiro desde os meus tempos de
acadêmico, minha eterna gratidão pelo convite para retornar à minha casa: a Santa Casa de
Misericórdia de São Paulo.
Ao Prof. Dr. Adhemar Monteiro Pacheco Junior, de quem tive a honra de ser aluno e
orientado.
Ao Doutor Seiji Nakakubo, por me receber tão amavelmente no Serviço de Endoscopia
Peroral, tornando menos árdua a execução deste trabalho e mais agradável o convívio no
Serviço de Endoscopia da Santa Casa de São Paulo.
Ao Prof. Dr. Lucio Rossini, pela oportunidade de participar do CFBEUS e pelo sábios
conselhos nesses anos de convivência.
Ao Dr. Marc Giovannini pelas ideias e brilhantes e pela simplicidade em resolver problemas
complexos.
Ao Dr. Rogério Colaiacovo pela amizade, e pela divisão de esforços para que os exames
pudessem ser realizados com a maior acurácia possível
Ao Dr. Augusto P. Carbonari pela incansável ajuda na tabulação dos dados e na elaboração
dos artigos.
Aos Drs. Haroldo Rocha, Ana Carolina Castro e Julia Araujo, por auxiliar no desenho dos
trabalhos, na coleta dos dados e preenchimento dos protocolos
À enfermeira Sheila Fillipi, pela sabedoria e retidão no tratar dos mais diversos problemas
durante o desenvolvimento do estudo.
À equipe de enfermagem do Serviço de Endoscopia Peroral da Santa Casa de São Paulo, que
sempre nos auxiliou com a execução dos exames.
Aos estagiários do Serviço de Endoscopia da Santa Casa de São Paulo que sempre auxiliaram
na execução dos exames.
Aos pacientes, que confiaram na eventual contribuição deste estudo para eles, ou para outros
com a mesma afecção.
SUMÁRIO
1- INTRODUÇÃO.................................................................................................................1
2- OBJETIVOS......................................................................................................................7
3- CASUÍSTICA E MÉTODO.............................................................................................8
4- RESULTADOS................................................................................................................10
4.1. Artigo 1: Rapid on-site cytopathological examination (ROSE)
performed by endosonagraphers and its improvement in the
diagnosis of pancreatic solid lesions. …………………………………………....10
4.2. Artigo 2: EUS-FNA of solid pancreatic lesions: a prospective,
randomized, single-blinded study comparing a core and a standard
22-gauge Endoscopic Ultrasound Needle. ............................................................20
5- COMENTÁRIOS FINAIS................................................................................................35
6- REFERÊNCIAS BIBLIOGRÁFICAS..............................................................................37
7- ANEXOS...........................................................................................................................52
1
1. INTRODUÇÃO :
Os tumores do pâncreas correspondem à quarta causa de morte por neoplasias nos
Estados Unidos e estima-se que passe a ser a segunda até o ano de 2030 (1, 2).
No Brasil, representa 2 % dos tumores em geral (3). A incidência é maior em homens
acima de 60 anos de idade, com um aumento significativo entre a sétima e a oitava década de
vida (4). É extremamente raro em pacientes abaixo dos 30 anos de idade (3).
Dentre os tumores pancreáticos, os adenocarcinomas ductais são os mais frequentes,
correspondendo a cerca de 90% do total (1, 5). Pórem, outros tipos também podem ser
observados, como os cistoadenocarcinomas, tumores neuroendócrinos, metastáticos, sólidocísticos dentre outros (6, 7).
A topografia mais frequente dos tumores sólidos pancreáticos é a cabeça, seguida da
cauda e do corpo (3).
A letalidade do câncer de pâncreas é alta e a sobrevida em 5 anos pode não chegar a
10% (8-10).
Recentemente, um grande estudo europeu, com centros de 28 países, demonstrou que
a sobrevida média dos pacientes com câncer de pâncreas, em 5 anos, não passou de 7%,
sugerindo o quão letal pode ser esta doença (11).
Infelizmente, ainda não se sabe a etiologia do câncer de pâncreas, mas sabe-se que
algumas síndromes familiares, como Peutz-Jeghers e Von-Hippel-Lindau são fatores de risco
importantes (12-17). Isso também ocorre em pacientes com pancreatites hereditárias, quando
até 40% dos pacientes podem desenvolver câncer de pâncreas, risco este que aumenta a 75%
nos casos de antecedentes familiares desta neoplasia (3, 18). Além disso, cerca de 10 a 15%
dos pacientes com câncer de pâncreas apresentam história familiar desta mesma neoplasia
(14, 19, 20).
2
Dentre os fatores ambientais, o tabagismo é o maior fator de risco. Porém, o etilismo,
o consumo de carnes e gorduras, assim como a exposição a solventes, também podem ter um
algum papel para o desenvolvimento da doença (17, 21).
Pessoas diabéticas e obesas, submetidas à gastrectomia ou colecistectomia, também
parecem apresentar um aumento na incidência de câncer de pâncreas (22).
Após o desenvolvimento da biologia molecular e da descoberta dos oncogenes, a
possibilidade do diagnóstico mais precoce passou a ser uma realidade. A mutação do gene Kras é bastante prevalente e estudada, podendo ser medida até durante a punção ecoguiada. No
entanto, os resultados destas medições são de casuísticas pequenas e de pouquíssimos centros
de pesquisa (23-25).
As mutações dos genes de supressão tumoral, como o P-53 estão presentes em até
70% dos pacientes com a doença e há estudos promissores referentes ao significado dessas
mutações, porém, ainda não se conseguiu demonstrar um verdadeiro impacto no diagnóstico e
na mudança do prognóstico da doença (26, 27).
O marcador tumoral mais utilizado na prática clínica é o CA19-9. Além de útil para o
diagnóstico, tem um papel muito importante para o acompanhamento da evolução dos
pacientes submetidos ao tratamento, seja este a quimioterapia ou a cirurgia (23).
Mesmo com todos esses avanços, o melhor prognóstico para os pacientes com câncer
de pâncreas reside no diagnóstico precoce. E, até os dias de hoje, ele é feito por dados clínicos
e exames de imagem. A ressonância magnética (RM) e a tomografia computadorizada (TC)
dão informações importantes sobre a doença, inclusive permitindo estadiar o tumor a
distância.
O exame de imagem mais utilizado e validado por trabalhos científicos, para o
diagnóstico dos tumores de pâncreas, é a tomografia computadorizada. A sensibilidade
diagnóstica varia de 89-97% (28), no entanto, para as lesões menores que 1,5cm ela cai para
3
cerca de 67%. Isso porque cerca de 25% dos tumores pancreáticos em estádios iniciais,
podem ter o mesmo sinal tomográfico que o parênquima subjacente (2, 29).
Por sua vez, os novos aparelhos de RM podem fazer o diagnóstico diferencial entre
adenocarcinoma e pancreatite crônica em lesões menores que 1cm. Segundo alguns estudos, a
sensibilidade pode chegar a 93% e a especificidade a 75% (30). Além disso, a RM pode
diagnosticar concomitantemente a presença de linfonodos e de metástases hepáticas pequenas,
além do acometimento dos vasos regionais, como a artéria mesentérica superior (30).
Contudo,
a
RM
não
permite
a
aquisição
de
fragmentos
para
estudo
anatomopatológico, mesmo que avalie bem o pâncreas anatomicamente. Já a TC, permite a
punção e aquisição de fragmentos em algumas oportunidades, dependendo da localização do
tumor.
Por mais difícil que seja a obtenção de material para estudo anatomopatológico, esta é
fundamental para se iniciar qualquer tipo de tratamento, seja ele curativo, paliativo, adjuvante
ou neoadjuvante (25, 31).
Hoje em dia, sabe-se que algumas características tumorais são responsáveis pela
melhor ou pior resposta à quimioterapia, por exemplo. Alguns desses dados só podem ser
obtidos através da biópsia (32).
Apesar do adenocarcinoma ser o tumor mais frequente, na vigência de outros tumores,
como os neuroedócrinos do pâncreas, tanto o prognóstico, quanto o tratamento mudam
completamente. E isso, às vezes, só pode ser definido com a aquisição de material (33, 34).
Devido à esta necessidade, a ecoendoscopia com punção surge como uma boa
alternativa para tal fim (31, 35).
O ultrassom e a endoscopia têm seus berços no século XIX. O primeiro teve a sua
origem em 1838, quando Bonnycastle tentou medir a profundidade do oceano através do eco.
Apesar de falhar na sua tentativa, ele impulsionou vários cientistas da época a desenvolverem
4
maneiras de utilizar o ultrassom a favor do homem. A descoberta da piezeletricidade em 1880
por Pierre e Jacques Curie, foi fundamental para que, finalmente, o homem pudesse manipular
o ultrassom (36, 37).
O naufrágio do Titanic, em 1912, impulsionou a ideia de que o oceano deveria ser
mapeado para rastrear os icebergs e outros objetos sob a superfície do oceano. Esses esforços
culminaram com o desenvolvimento do sonar em 1914 (36). Mais de 20 anos após, em 1937,
o psiquiatra e neurologista, Karl Theodore Dussik, em associação com o seu irmão Friedrich,
descreveram a primeira aplicação clínica do ultrassom, ao tentarem mapear o cérebro humano
(38).
Em 1950, Julian Wild mediu a espessura da parede gástrica em uma peça de câncer e a
dividiu ecograficamente em 3 camadas (39). O mesmo Wild, Neil e, posteriormente Reid,
relataram que os tumores tinham aspecto hiperecogênico, quando comparados ao tecido
normal. Em alguns desses estudos, eles inseriram sondas retais para o diagnóstico de tumores
(38-42).
No entanto, o trabalho que revolucionou o uso do ultrassom da prática clínica foi
publicado em 1958 por Donald et al. (43). Nesse relato, este ginecologista fez o diagnóstico
de um tumor ovariano em uma paciente cujo diagnóstico anterior era de neoplasia gástrica.
Assim como o ultrassom, a endoscopia também tem a sua origem na primeira metade
do século XIX. Bozzini inventou o primeiro condutor de luz para cavidades em 1806 (44). A
palavra endoscopia, parece ter sido descrita por Desormeaux (36). Em 1868, após assistir a
um show de um engolidor de espadas, Kussmaul introduziu um tubo rígido no esôfago de um
paciente. Em 1881, estimulado pelo feito de Kussmaul e com o auxílio da recém inventada,
lâmpada de Desormeaux, Mickulicz realizou a primeira endoscopia no mundo (45).
Assim como o ultrassom, o grande salto da endoscopia foi dado no meio do século
passado, com o desenvolvimento da fibra óptica, nas décadas de 1950 e 1960 (46).
5
Após caminharem separadas por mais de 100 anos, uma observando os órgãos por fora
enquanto a outra os observava por dentro, as duas tecnologias foram unidas
experimentalmente em 1976, quando Lutz e Rosh inseriram um “probe” ultrassonográfico
por dentro do canal de biópsia de um endoscópio, para estudar lesões intraluminais (47).
No entanto, com a criação do ecoendoscópio em 1980, as duas tecnologias,
finalmente, se uniram em um só aparelho (48). Surgiu assim, uma nova maneira de estudar os
órgãos do trato digestório: a ecoendoscopia.
Porém, os avanços não cessaram e, a partir da década de 1990, novas possibilidades
surgiram com o desenvolvimento das agulhas para punções ecoguiadas, que permitiam a
aquisição de tecidos e a realização de biópsias além da luz intestinal (49-52).
As punções das lesões de órgãos sólidos do trato gastrointestinal, como o pâncreas,
foram um grande avanço, principalmente, devido à gravidade das neoplasias pancreáticas e do
seu complexo tratamento (53-56). Além disso, sem o tecido adquirido durante as biópsias para
diagnosticar ou descartar uma neoplasia maligna, o tratamento desta pode ser retardado, com
consequência prognóstica na evolução do paciente.
Apesar de todo o progresso, as biópsias ecoguiadas ainda estão longe de atingir a
perfeição. Seja pela sensibilidade do método, que continua em cerca de 90%, pela necessidade
de patologistas especializados ou pelas características próprias de cada lesão (57, 58). O fato é
que, nos últimos 10 anos, pouco se observou de melhora em relação à performance do
diagnóstico ecoendoscópico das lesões sólidas pancreáticas.
Mais recentemente, algumas modificações da técnica da punção ecoguiada, como o
surgimento de uma nova agulha e a realização de citologia na sala de exame, parecem ter
melhorado a performance da punção ecoguiada das lesões sólidas pancreáticas (37, 59-62).
Por não existir nenhuma publicação nacional estudando essas duas novas
possibilidades, durante a realização da ecoendoscopia com punção das lesões sólidas do
6
pâncreas, há a necessidade de estabelecer a importância de novos métodos que possam
fornecer espécimes em condições para o diagnóstico histopatológico, contribuindo na
definição pré-operatória das lesões sólidas do pâncreas.
7
2. OBJETIVOS:
Avaliar a contribuição de duas novas técnicas de punção guiada por ecoendoscopia
das lesões sólidas pancreáticas, através de dois artigos científicos dentro da linha de pesquisa:
“Estudo ecoendoscópico das neoplasias pancreáticas”, em desenvolvimento no Centro Franco
Brasileiro de Ecoendoscopia.
8
3. CASUÍSTICA E MÉTODO:
A presente linha de pesquisa sobre a avaliação ecoendoscópica das neoplasias
pancreáticas teve início em 2009, no Centro Franco-Brasileiro de Ecoendoscopia do Serviço
de Endoscopia Peroral da Santa Casa de São Paulo. Nesses seis anos, foram incluídos 78
pacientes com lesões sólidas pancreáticas em dois protocolos diferentes e que originaram 2
trabalhos sobre o tema. O primeiro trabalho foi retrospectivo e estudou a realização da
citologia em sala, realizada pelo próprio endoscopista.
Todos os pacientes com lesões sólidas pancreáticas que foram submetidos à punção
ecoguiada de 2009 a 2011, num total de 48 pacientes, foram incluídos neste protocolo de
pesquisa.
Esse protocolo originou o artigo: “Rapid on-site cytopathological examination (ROSE)
performed by endosonographers and its improvement in the diagnosis of pancreatic solid
lesions”, já publicado na revista “Acta Cirúrgica Brasileira”, com classificação Qualis B1.
Após a conclusão do primeiro protocolo, um novo tipo de agulha para a realização de
punções guiadas por ecoendoscopia foi desenvolvida nos Estados Unidos, com a expectativa
de melhorar a performance da punção guiada por ecoendoscopia.
Em julho de 2012, iniciou-se um novo protocolo de pesquisa com 30 pacientes
avaliados prospectivamente, nos quais foi realizada a ecoendoscopia com punção com a
agulha tradicional e com o novo tipo de agulha (ProCoretm). O protocolo foi encerrado em
novembro de 2013.
Esse segundo protocolo de pesquisa originou o artigo: “EUS-FNA of solid pancreatic
lesions: a prospective, randomized, single-blinded study comparing a core and a standard 22gauge Endoscopic Ultrasound Needle”. Este trabalho foi selecionado para apresentação oral
no Congresso Europeu de Ecoendoscopia de 2014 e foi apresentado na semana do aparelho
9
digestivo dos Estados Unidos (DDW 2014). O artigo foi enviado ao periódico “Surgical
Endoscopy and Other Interventional Techniques (Print)”, com classificação Qualis A2.
Seguindo as normas da Pós-Graduação da Faculdade de Ciências Médicas da Santa
Casa de São Paulo de junho de 2013, o detalhamento da metodologia utilizada durante a
pesquisa, encontra-se descrito em cada um dos artigos reproduzidos a seguir.
10
4. RESULTADOS:
4.1. Artigo 1. Publicado no periódico Acta Cirúrgica Brasileira; indexado como Qualis
B1.
Ganc RL, Carbonari AP, Colaiacovo R, Araujo J, Filippi S, Silva RA, Pacheco Junior AM,
Rossini LG, Giovannini M. Rapid on-site cytopathological examination (ROSE) performed
by endosonagraphers and its improvement in the diagnosis of pancreatic solid lesions. Acta
Cir Bras2015 Jul;30(7):503-8.
CLINICAL INVESTIGATION
Rapid on-site cytopathological examination (ROSE) performed by
endosonagraphers and its improvement in the diagnosis of pancreatic solid
lesions1
Ricardo Leite GancI, Augusto Pincke Cruz CarbonariI, Rogério ColaiacovoI, Júlia
AraujoIII, Sheila FilippiIV, Rodrigo Altenfender SilvaV, Adhemar Monteiro Pacheco
JuniorV, Lucio Giovanni Battista RossiniII, Marc GiovanniniVI
I
MD, Endoscopy Unit, Faculty of Medical Sciences, Santa Casa of Sao Paulo (FCMSCSP), Brazil.
Conception and design the study, analysis of data, endoscopic procedures and on-site cytopathological
examination, manuscript preparation.
11
II
PhD, Endoscopy Unit, Faculty of Medical Sciences, FCMSCSP; Chief of the Endoscopy department
of Sirio-Libanes Hospital Sao Paulo-SP, Brazil. Conception and design the study, critical revision,
final approval.
III
Resident, French Brazilian Centre of Endoscopic Ultrasound (CFBEUS), Sao Paulo-SP, Brazil.
Analysis of data.
IV
Nurse, French Brazilian Centre of Endoscopic Ultrasound (CFBEUS), Sao Paulo-SP, Brazil.
Endoscopic procedures and on-site cytopathological examination.
V
MD, MSc, PhD and Associate Professor, Department of Surgery, FCMSCSP, Critical revision, final
approval.
VI
MD, Endoscopy Unit, Institut Paoli-Calmettes, Marseille, France. Conception and design the study,
critical revision, final approval.
ABSTRACT
PURPOSE: To evaluate the diagnosis improvement of EUS-FNA when using ROSE performed by
the endosonographer.
METHODS: A retrospective study was conducted. A total of 48 pancreatic solid masses EUS-FNA
were divided into two groups according to the availability of on-site cytology (ROSE) – the first 24
patients (group A-without ROSE) and the latter 24 cases (group B-with ROSE). Sensitivity,
specificity, positive predictive value, negative predictive value, accuracy, complications and
inadequacy rate of EUS-FNA were determined and compared.
RESULTS: Among the 48 EUS-FNA, the overall performance was: sensitivity 82%; specificity
100%; positive predictive value (PPV) 100%; negative predictive value (NPV) 70% and accuracy
87%. The sensitivity of the Group A was 71%, versus 94% in-group B (p=0.61). Moreover, the
negative predictive value was 58% versus 87% (p=0.72). The accuracy rate increased from 79% to
96% (p=0.67) in the ROSE group. The number of punctures was similar between the groups. No
major complications were reported.
CONCLUSION: Rapid on-site cytopathological examination, even when performed by the
12
endosonographer, may improve the diagnostic performance in the diagnosis of solid pancreatic
lesions, regardless of the slight increase in the number of punctures.
Key words: Endosonography. Pancreatic Neoplasms. Cell Biology.
Introduction
Endoscopic ultrasound (EUS) was introduced in clinical practice in 1980 in order to
improve the appreciation of the digestive tract walls and adjacent structures. Later, with the
development of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA), obtaining
tissue specimen was made possible; thereby further improving its accuracy (36, 48, 63).
EUS is the most accurate method for loco-regional staging of upper gastrointestinal
cancers, with well-established clinical impact, influencing decision-making and patient
management.
Furthermore, EUS-FNA proved to be a safe, accurate, and a reliable diagnostic
procedure, with a high diagnostic and therapeutic yield (64). The rapid on-site
cytopathological examination (ROSE) during the procedure appears to have a significant
impact on EUS-FNA success rates (65).
The objectives of the study are to determine the overall performance of EUS-FNA in
the diagnosis of solid pancreatic lesions in a Latin American EUS training center and to
evaluate the diagnosis improvement of EUS-FNA when using ROSE performed by the
endosonographer.
Methods
This is a single center prospectively enrolled retrospective study, including all patients
referred for EUS examinations for pancreatic solid lesions from January 2009 to November
13
2011. The study was conducted at the French-Brazilian Centre of Endoscopic
Ultrasonography (CFBEUS), located at the endoscopy unit of Santa Casa of Sao Paulo
Hospital, Brazil.
After obtaining formal informed written consent, an anesthesiologist sedated all patients.
EUS-FNA was performed by using an EG-530UT linear echoendoscope and SU-7000
ultrasonic processor (Fujinon, Saitama, Japan) and 22-G EchoTip® needle (Cook Medical Inc,
Limerick, Ireland).
During the study period, a total of 963 EUS examinations were performed, of which, 71
EUS-FNA of suspected pancreatic lesions were evaluated, including 48 solid lesions and 23
cystic lesions.
The present article regards pancreatic solid lesions, therefore, only the 48 EUS-FNA of
such lesions were included. Single and multiple FNA passes (1 to 7 passes) were done in the
first 24 EUS-FNA cases (group A) (figures 1 A and B). For the latter 24 cases (group B),
EUS-FNA passes were performed until ROSE evaluation confirmed the presence of a
sufficient number of representative lesion cells. The same endosonographer performed the
fine needle aspirates and prepared the cytology slides using the Diff-Quik® stain set. The
tissue specimens obtained were also immediately formalin-fixed for further cell-block study.
FIGURE 1 A and B: EUS-FNA of a pancreatic mass.
The endosonographer had sufficient experience in more than 300 pancreatic and biliar
EUS-FNA procedures and underwent formal cytology training with the cytopathologist. This
14
included at least 30 hours of theoretical-practical and review of slides, with the boardcertified cytopathologist demonstrating examples of adequate, inadequate, benign and
malignant slides (Figure 2).
FIGURE 2: Cytology slide: pancreatic adenocarcinoma (Diff-Quik stain®).
For the EUS-FNA procedures, the standard suction technique was used, with the 10 mL
syringe that is part of the EchoTip® needle kit.
The final diagnosis was based on the examination of the results of the slides, the cell-block
and surgical pathology specimens. Technical failure was considered when there was
insufficient aspirated material to determine a final diagnosis, according to the pathologist and
this datum was used to calculate the inadequacy rate.
The definition of complications followed the same criteria used by the American Society
for Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy
(ESGE) guidelines (66, 67).
All patients signed an informed consent and the ethics committee of the institution
approved the study.
Statistical analysis
15
Initially, all variables were analyzed descriptively. For quantitative variables, the analysis was
done through observation of minimum and maximum values and the calculation of mean
values, standard deviations. For qualitative variables, we calculated absolute and relative
frequencies. To compare the proportions of failures of the methods we used the Fisher’s Exact
Test. To study the efficiency of the methods we analyzed the values of sensitivity, specificity,
accuracy, positive and negative predictive values. The significance level used for the tests was
5%.
Results
Among the 48 EUS-FNA of pancreatic solid masses, the overall performance was: sensitivity
82%; specificity 100%; positive predictive value (PPV) 100%; negative predictive value
(NPV) 70% and accuracy 87%.
The sensitivity of the Group A was 71%, versus 94% on group B (p=0.61). The specificity of
both groups was 100%, as well as the positive predictive value. Moreover, the negative
predictive value was 58% versus 87% (p=0.72). The accuracy rate increased from 79% to
96% (p=0.67) on the ROSE group. These results can be appreciated in Table 1.
TABLE 1: Performance for EUS-FNA of pancreatic solid lesions.
The inadequacy rate (insufficient material) on Group A was 20.8 % (5/24 patients) and 4.15%
16
(1/24 patients) in-group B (p=0.19). All of these patients died of advanced disease and were
considered false negative (6/48-12.5%). In-group A, the number of punctures ranged from 1
to 6 with a mean value of 3.5. In-group B, the number of punctures ranged from 3 to 8, with a
mean value of 4.3. These results were not statistically significant. There were no major
complications in this study. Two patients in group A (8.3%) and 3 (12.5%) in group B with
immediate mild abdominal pain, which resolved with analgesics and did not prolong hospital
stay. Two patients (8.3%) in each group complained of soar throat for a few days that
resolved with oral Benzocaine.
The most common diagnosis is the pancreatic adenocarcinoma, followed by the results of
non-neoplastic diseases such as pancreatitis and normal pancreatic tissue, as shown in figure
3.
FIGURE 3: Final histologic diagnosis of the punctured lesions.
Discussion
17
Pancreatic adenocarcinoma is the second most common gastrointestinal malignancy and the
fourth leading cause of cancer-related mortality in the United States (10).
EUS has well-defined accuracy in GI malignancies stages and is the most accurate method in
establishing the presence of pancreatic lesions, but cannot alone, reliably differentiate benign
from malignant lesions. Consequently, pathological examination is often required to establish
a definitive diagnosis (68-71).
EUS-guided fine needle aspiration (EUS-FNA) was first described in 1991 for the evaluation
of gastric sub-mucosal lesions and pancreatic cancer (49, 72).
For EUS-FNA of pancreatic lesions, many different needles can be used, nonetheless. The
results don’t appear to change much and the complication rate may increase when using a
19G. Therefore we adopted the 22G needle for this study.
Even though, nowadays different suction techniques may be applied, such as slow-pull, or no
suction at all, at the time of the beginning of the protocol, that was not an issue and it was not
considered as a variable then.
There are studies that have examined the improvement of diagnostic ability of EUS-FNA
without on-site cytopathologist, but with the immediate microscopic inspection by
endosonographers (73, 74). In a retrospective study, Savoy et al. compared the abilities of
endosonographers and cytotechnologists in the immediate evaluation of microscopic
inspection. The respective accuracies were of 70% and 89%(74). In our study, the ROSEgroup accuracy was 96%, which can be considered similar to the cytotechnologists on
Savoy’s study.
In contrast, Erickson et al. (75) and Nasuti et al. (76) showed that the absence of ROSE at all,
resulted in poor diagnostic accuracy as well as increased procedure time, number of needles
used, and overall examination costs.
18
More recently, Iglesias-Garcia et al. demonstrated that ROSE decreased the number of passes
with the EUS needle, the inadequacy of the collected specimen, as well as was associated
with a significantly higher diagnostic sensitivity (96.2 vs. 78.2%; p=0.002) and overall
accuracy (96.8 vs. 86.2%; P=0.013) for malignancy(77).
In our study, after ROSE performed by the endosonographer, the sensitivity increased from
71% to 94% (p=0.61), the negative predictive value from 58% to 87% (p=0.72) and the
accuracy from 79% to 96% (p=0.67). The insufficient aspirated material decreased from
20.8% to 4.1% (p= 0.19). Although, not statistically significant, ROSE increased the accuracy
of the method and reduced technical failure. Iglesias-Garcia et al. observed the same pattern
in the previously quoted study, although their inadequacy rates were lower than ours
altogether (12.6% without ROSE and 1% with ROSE). We could argue whether the
pathologists of their group are better acquainted with pancreatic cytology or that technically
the endosonographer of our study is less experienced.
With that in mind and using our data as a starting point, we have an ongoing prospective
study in our center, on ROSE, where we intend to enroll a larger sample size.
Nonetheless, our data is similar to other articles in this field, such as the meta-analysis
recently published by Hewitt et al. In his study the pooled sensitivity for malignant cytology
was 85% and pooled specificity was 98% (78).
One may wonder how we managed, in a retrospective study, to have exactly 24 patients in
each group. The manner we chose to draw the protocol explains that. The idea was to finish
the study in three years. When we reached 18 months in the study, we concluded the first
group. The number of patients enrolled was 24. Therefore, we decided to perform ROSE, in
the following 24 patients. The data acquired was analyzed retrospectively. That’s why, this
may be called a prospectively enrolled retrospective study.
In the present article, the appliance of ROSE caused the mean number of punctures to
19
increase from 3.5 to 4.3. Even though this was not significant, it was somehow unexpected,
since ROSE is thought to decrease the number of punctures needed to confirm the diagnosis,
as suggested by Iglesias-Garcia (77). Some may argue that the increase in the number of
punctures, might justify the better result by itself, leaving no benefit for the ROSE procedure.
We do not believe that, because, the number of punctures did not differ that much (3.5 - 4.3)
and was far from being significant.
On the other hand, the apparent improvement in performance and the decrease of inadequate
material samples justifies the use of ROSE.
There were no major complications in this study. As previous articles demonstrated, EUSFNA is a safe procedure with a complication rate of approximately 1-2%. Major
complications include infection, bleeding, and acute pancreatitis and are more frequent for
EUS-FNA of cystic compared with solid lesions (66, 67, 78).
The main difference between this study and the others is the fact that, the number of
punctures needed for diagnosis with ROSE did not decrease, on the contrary. Nonetheless, the
apparent improvement in performance, suggests that this is not an issue, as long as this trend
proves to be true. Most likely, larger and multicenter trials might be able to do so.
Conclusion
Rapid on-site cytopathological examination, even when performed by the endosonographer,
may improve the diagnostic performance in the diagnosis of solid pancreatic lesions,
regardless of the slight increase in the number of punctures.
1
Research performed at Endoscopy Unit, French-Brazilian Centre of Endoscopic Ultrasonography
(CFBEUS), Faculty of Medical Sciences, Santa Casa of São Paulo (FCMSCSP), Brazil
20
4.2.
Artigo 2. Enviado ao periódico Surgical Endoscopy and Other Interventional
Techniques” (Print); indexado como Qualis A2.
Aguardando resposta.
Title:
EUS-FNA of solid pancreatic lesions: a prospective, randomized, single-blinded study
comparing a core and a standard 22-gauge Endoscopic Ultrasound Needle.
Authors
Ricardo Leite Ganc, Rogério Colaiacovo, Augusto Pincke Cruz Carbonari, Haroldo Luis
Rocha, Sheila Filippi, Rodrigo Altenfender Silva, Adhemar Monteiro Pacheco Junior, Lucio
Giovanni Battista Rossini, Marc Giovannini.
Keywords: Endosonography; Pancreatic neoplasms; Endoscopic Ultrasound-Guided Fine
Needle Aspiration; Diagnosis.
Abbreviations: EUS-FNA=Endoscopic Ultrasound Fine needle aspiration; PPV= Positive
predictive value; NPV= Negative predictive value; G=gauge
21
ABSTRACT
Background and aims: Recently, a new core needle was developed in order to improve
diagnostic accuracy of EUS-FNA, potentially decreasing the procedural time. The present
study intends to compare the diagnostic performance of EUS-FNA using a core and a
standard 22-gauge in the same patient with pancreatic solid masses, during the same EUS
procedure.
Methods: This is a prospective, randomized, single blinded, comparative study. It was
performed in a single tertiary University Center. Thirty consecutive patients with solid
pancreatic lesions were enrolled to have EUS-FNA performed with a core needle (A - 1 pass
and 4 to and fro movements) and a standard needle (B - 3 passes with 10 to and fro
movements). The order of the punctures was randomized and the pathologist did not know
which specimen was from which needle. The McNemar test for discrete pair data was used
(P<0.05).
Results: The results were similar regarding introduction, exposition and removal of the
needles. There was no difference in sensitivity (92% for both needles), specificity (100% - A
x 80% - B), PPV (100% - A and 95.8% - B), NPV (71.4% - A and 66.6% - B) and accuracy
(93.3% - A and 90% - B).
Conclusion: The core needle achieved the same level of performance as the standard needle.
The quicker procedure time did not impact in the overall performance.
22
INTRODUCTION
Despite the latest advances in tumor diagnosis, the prognosis of pancreatic cancer is one of
the poorest among all malignant tumors (79). Endoscopic ultrasound-guided fine needle
aspiration (EUS-FNA) is considered one of the most accurate methods for the differential
diagnosis of solid pancreatic lesions (79-82).
The diagnostic yield of EUS-FNA for pancreatic lesions depends on factors such as, location
and nature of the tumor, experience of the endosonographer and cytopathologist and maybe,
the type of the needle used for the procedure (83-85). EUS-FNA with standard needles (19, 22
or 25 gauges) may provide adequate tissue for histopathological evaluation of pancreatic
tumors in most patients, but not in all (86-88).
One limitation of EUS-FNA with standard needles is the small amount of specimens obtained
and, as a consequence, inconclusive diagnosis in some cases (88).
To this point, the European Society of Gastrointestinal Endoscopy (ESGE) Technical
Guideline suggests that, different needles, with their own characteristics are suitable to
correctly diagnose different TGI masses (66).
Recently, a new needle (ProCoretm - Wilson Cook, Winston Salem, NC) became available in
the 19, 22 and 25-gauge diameters (89-91). The needle has a reverse bevel that promotes
collection of core sample by shearing material from the target lesion, during retrograde
movement of the needle (59).
Furthermore, this new type of needle appears to allow fewer passes than the usual needle in
order to carry out the diagnosis, keeping the same accuracy (84, 92, 93). Potentially, this
could prevent some adverse effects, besides decreasing the time required to perform the EUSFNA. There are few articles comparing the ProCoretm with standard needles. Moreover, the
vast majority of the studies compare the punctures with each needle in different patients,
23
while this study, is one of the few to use both needles in the same patient, during the same
procedure (80, 87, 88).
OBJECTIVES
The main objective of this study was to compare the accuracy of diagnosis of EUS-FNA using
two different 22-gauge needles (EchoTip®ProCoreTM HD and EchoTip® Ultra HD) in the
same patient with pancreatic solid masses, during the same EUS procedure.
The secondary objectives were to compare the ease of use of each needle and to determine
whether the quicker EUS-FNA with the EchoTip®ProCoreTM HD, could translate into a
poorer diagnostic performance.
PATIENTS AND METHODS
This was a prospective, single-blinded, randomized controlled trial with thirty consecutive
patients with pancreatic solid lesions enrolled at a single institution from July 2012 to
November 2013.
The trial study was fully conducted at a tertiary University Hospital and was approved by the
ethics committee of the Faculdade de Ciências Médicas da Santa Casa de São Paulo.
The inclusion and exclusion criteria were:
Patients with solid pancreatic masses, previously diagnosed by CT-scan that agreed to
participate in this study, by signing an informed consent form, were included in the study.
Patients with coagulopathy (INR>1.5 or thrombocytopenia with a platelet count
<50,000/mm3), infection, mixed type lesions; patients without a safe EUS-FNA window and
those who refused to sign the informed consent were excluded prior to the study.
24
EUS-FNA was performed in all patients with both needles during the same procedure.
Lesions in the head and uncinate process were punctured through the duodenum, while
lesions in the body and tail of the pancreas were punctured through the stomach.
A computer-generated randomization program determined the order of the needles used in
each case. The result of the order of the needle was put inside 30 envelopes and they were
opened as soon as the procedure had started.
EQUIPMENT
The echoendoscope used was the linear Fujinon EG-530UT with ultrasound processor SU7000 and endoscopic processor EPX-4400 (Fujinon, Saitama, Japan).
The needles used were the 22-Gauge EchoTip®ProCoreTM HD (Wilson Cook, Winston
Salem, NC) and the 22-Gauge EchoTip® Ultra HD (Cook Medical Inc, Limerick, Ireland).
PROCEDURAL TECHNIQUE
All Patients were placed on the left lateral decubitus position, under propofol sedation by the
anesthesiologist.
After the echoendoscope was inserted and the lesion studied in detail, tissue acquisition was
performed using both needles by one of two-experienced endosonographers.
The order of the needle to be used was predetermined by the computer-generated
randomization. The envelope with the randomization of the needle was opened and read to the
examiner.
Before the needle was passed, an electronic chronometer was used in order to measure the
time of the procedure. It was stopped when the needle was last removed after the punctures.
25
For the 22-Gauge EchoTip®ProCoreTM HD, called needle A from now on, only one puncture
was performed with 4 to-and-fro movements using the stylet and the suction technique (10ml
syringe) for 20 seconds. The needle was then removed and the chronometer stopped.
For the EchoTip® Ultra HD, called needle B from now on, three punctures were performed,
with 10 to-and-fro movements using the stylet and the fanning technique with suction (10 ml
syringe).
After each puncture, the sample was obtained by flushing saline solution and by reinserting
the stylet in the needle. After that, a new puncture (only for needle B group) was performed.
The chronometer was stopped when the needle was last removed from the echoendoscope.
On-site cytology was not available for this study.
The samples obtained were placed in formalin and sent for histologic evaluation (Cell block),
by a single experienced pathologist, who was blinded to the order of the needle used, since
the samples of each patient were simply labeled 1 and 2.
OUTCOME PARAMETERS
The main objectives were to measure and compare the sensitivity, specificity, PPV, NPV,
accuracy of the procedure using each of the needles.
The secondary objectives were to evaluate and compare, ease of introduction, exposition and
removal of each needle. We also wanted to evaluate whether the quicker procedure time
expected with the needle B, would decrease the diagnostic performance.
The gold standard was considered surgery or clinical follow-up for 12 months, for those
patients who were not operated on.
All patients were kept under observation for at least 2 hours after the procedure. If no
abdominal tenderness, pain or other clinical signs of complications were noticed, they were
26
discharged to go home. Early adverse effects were assessed via a telephone call after 24
hours.
The definition of adverse effects followed the same criteria used by the American Society for
Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy
(ESGE) guidelines (66, 67).
STATISTICAL ANALYSIS
For quantitative variables, the analysis was done through observation of minimum and
maximum values and the calculation of mean values and standard deviations.
In order to study the efficiency of the needles, we analyzed the values of sensitivity,
specificity, accuracy, positive and negative predictive.
Rates of adverse effects were also analyzed, but not compared, since it would not be possible
to determine which needle caused an eventual adverse effect.
In order to compare the results, we used the McNemar test for discrete paired data. The
significance level used for the tests was 5%.
RESULTS
During the study period, a total of 30 patients were evaluated.
An adequate window for the EUS-FNA was achieved in all patients.
The mean age of the patients was 62 years (32-82) and 47% were male. For signs and
symptoms, we observed weight loss in 94%, abdominal pain in 77%, jaundice in 57%, itching
in 17%, diarrhea in 7%, cholangitis in 3% and palpable abdominal mass in 3% of the cases.
For associated diseases, we observed diabetes in 27%, hypertension in 24%, lung disease in
27
7% and liver disease in 3% of the cases. The demographic data, signs and symptoms and
associated diseases are listed in table 1.
The location of the pancreatic mass was: head in 22 (74%), body in 3 (10%), uncinate in 3
(10%) and tail of the pancreas in 2 cases (6%). The mean size of the lesions was 3.5 cm (1.55.7mm). The margins were irregular in 27 (90%), poorly defined in 25 (84%) and well
defined in 5 patients (16%). All the lesions (100%) were hypoechoic and heterogeneous.
Adjacent organ invasion was observed in 13 cases (43%): duodenum in 8 (27%), common
bile duct in 4 (13%) and papilla in 1 case (3%). The characteristics of the lesions can be seen
in table 2.
There was a similar histological diagnosis for both needles in 24 patients (80%): 17 cases
(57%) of pancreatic ductal adenocarcinoma, 4 cases (14%) of negative result for malignancy,
1 case (3%) of atypical cells, 1 case (3%) of benign change and 1 case (3%) of inflammatory
changes.
Of the 4 negative cases for both needles, 2 were considered false negatives, since these
patients died of advanced pancreatic cancer during the follow-up period.
The histological diagnosis differed between needles in 6 patients (20%): Three cases were
considered as pancreatic ductal adenocarcinoma in needle A, while only positive for neoplasia
in needle B; one case was negative for neoplasia in needle A, while suspect for neoplasia in
needle B. This case (patient R.S.J.) was identified as a false positive for needle B, because the
patient was alive and well in his 12 month follow-up (table 3).
One case was suspect for neoplasia in needle A, while positive for neuroendocrine tumor in
needle B and 1 case was suspect for neoplasia in needle A, while positive for a pancreatic
ductal adenocarcinoma in needle B.
For comparison purposes, the cases where the result was “suspect for neoplasia” were
considered as positive for neoplasia.
28
There was no difference (P=1.0) with regard to introduction, exposition and removal of the
needles. Similarly, there was no statistical difference between the needles for the values of
sensitivity (92% for needles A and B), specificity (100% for needle A and 80% for needle B),
positive predictive value - PPV (100% for needle A and 95.8% for needle B), negative
predictive value - NPV (71.4% for needle A and 66.6% for needle B) and accuracy (93.3%
for needle A and 90% for needle B).
No adverse effects were observed during the study period.
Since the methodology chosen compared 1 punction, for needle A, with 3 punctions of needle
B, it was expected that the needle A would be quicker to perform the EUS-FNA procedure.
This was measured and the average time spent for needle A was 2m26s (1m30s - 4m0s) and
for needle B 11m7s (6m0s - 17m0s) (p<0.0001). This quicker technique, did not impact
negatively in the result, as sensitivity and specificity were not statistically different.
The results of the full comparison between the needles are shown in table 3.
DISCUSSION
EUS has well-defined accuracy in the diagnosis of malignancies of the gastrointestinal tract
and its surroundings and is one of the most accurate methods in establishing the presence of
pancreatic lesions, but cannot alone, reliably differentiate benign from malignant lesions (52,
94-96). Consequently, pathological examination is often required to establish a definite
diagnosis (70, 71).
EUS-FNA with standard needles (19, 22 or 25 gauges) can provide tissue that is adequate for
histopathological evaluation from most pancreatic tumors (66, 86). A recent meta-analysis, by
Puli et al., including 41 studies and 4,766 patients with solid pancreatic lesions, demonstrated
an overall sensitivity of 86.8% and a specificity of 95.8% (97).
29
Nonetheless, many factors play different roles in improving the accuracy of EUS-FNA, one of
them being the type of needle. Therefore, recently, a new needle (EchoTip®ProCoretm HD Wilson Cook, Winston Salem, NC) has become available.
A few articles have been published comparing this new ProCoretm needle with the usual EUSFNA needle.
One of the assumption is that the new core needle, is able to improve the quality, and,
consequently, the accuracy of diagnosis. Our study, as well as others, did not find that to be
accurate (98).
The present study shows the performances of EUS-FNA using a core and a standard 22-gauge
endoscopic ultrasound needles. The results of both needles for sensitivity, specificity, positive
and negative predictive values and accuracy were similar.
One may argue that considering the “suspicious for neoplasia” as a positive result is not
proper, since it is not enough to start medical treatment. We only considered them positive,
for comparison purposes. Moreover, Shi et al., recently published an article, with 29 patients
in which the results were suspicious for neoplasia he refers that, if there is a very strong
clinical suspicion of cancer, it may be proper to start chemotherapy for such patients (99).
In our study, we observed the sensitivity and specificity to be: 92% and 100% for the core
needle and 92% and 80% for the standard needle. For instance, a recently published
multicenter randomized study from France found similar results (93). The common points
between our studies were that, in both, only one pass was made with the core needle,
nonetheless, they used two passes for the regular needle, while we used three passes.
In another study, Hucl et al. used both needles in pancreatic masses and peri-intestinal
lymphadenopathy. Even though he did not use only one pass with the core needle, he found
its capacity to correctly diagnose pancreatic lesions to be slightly better than the standard
30
needle (86.8% x 75% -p=0.046). For lymphadenopathy, the standard needle was better than
the core needle needle (85.9% x 71.8% -p=0.02) (92).
As expected, the ProCoretm needle procedure was much quicker (2m26s x 11m7s). That is not
part of our comparison, since it was expected due to the chosen methodology.
Nonetheless, we found that this quicker procedure did not impact negatively in the overall
performance of the core needle.
Other studies, also accomplished comparable results with the core and the regular needle with
fewer passes (83, 84, 93, 94). One could argue that the only way to prove that the core needle
procedural time is quicker than the regular needle is to perform exactly the same methodology
with both needles.
Since when we started the protocol, there was no article advocating that one pass with the
standard needle was ideal to properly make the diagnosis of pancreatic solid lesions, we
didn’t think it would be acceptable to do so. On the other hand, puncturing a patient 6 times,
would also add extra time and unnecessary punctures, potentially increasing the number of
adverse effects. Therefore, we chose the methodology described.
Nonetheless, Bang et al. also comparing 22-G needles in pancreatic solid masses observed
that the results were similar, even with only one pass for each needle. This is something that
should be looked at and more studies with the same methodology should be applied either to
confirm their findings or not (87).
Potentially, fewer passes and a shorter procedural time could decrease the morbidity of EUSFNA, although there were no adverse effects in this study, thus making it an unproven
hypothesis. This data was not compared. Mainly because we used both needles during the
same procedure and it would be impossible to compare their complication rates.
A critical point in the present study is the use and definition of the criterion-standard
reference method. Ideally, when the pathology results of the EUS-FNA are negative,
31
histological confirmation from surgical specimens would be the criterion standard, which
cannot be obtained for ethical reasons in patients in whom surgery is not indicated. In these
specific cases, clinical follow-up for at least 12 months with repeated imaging procedures was
used in our study. Although not ideal, this method is a well-accepted reference standard.
We understand that with a cohort size of 30 samples per arm, the study has its limitations and
it maybe, underpowered. Nonetheless, this fact warrants the need for large multicenter
randomized trials in order to confirm such findings.
CONCLUSION
The present study demonstrated that the 22-gauge Procoretm needle had an equivalent
performance to the standard 22-gauge needle for EUS-FNA of solid pancreatic lesions in our
setting. The quicker procedure time with this needle, did not impact negatively in its
performance.
32
TABLES:
Table 1: Demographic characteristics of the 30 patients who underwent
EUS-FNA of solid pancreatic masses.
Age, mean (minimum-maximum), y
62 (32-82)
Sex (male/female)
14/16
Signs and Symptons
-weight loss (%)
94
-abdominal pain (%)
77
-jaundice (%)
57
-itching
17
-diarrhea
7
-cholangitis
3
-palpable abdominal mass
3
Associated diseases
-diabetes
27
-hypertension
24
-lung disease
7
-liver disease
3
33
Table 2: Anatomic and echographic characteristics of the solid
pancreatic lesions.
Location, n(%)
-head
22 (74%)
-body
3 (10%)
-uncinate process
-tail
3 (10%)
2 (6%)
Size, mean (minimum-maximum), mm
35 (15-57)
Borders, n(%)
-irregular
27 (90%)
-poorly defined
25 (84%)
-well defined
5 (16%)
-regular
3 (10%)
Echogenicity, n(%)
-hypoechoic
30 (100%)
-heterogeneous
30 (100%)
-hyperechoic foci
4 (13%)
-cystic areas
2 (6%)
Invasion of adjacent organ, n (%)
13 (43%)
-duodenum
-common bile duct
8 (27%)
4 (13%)
-papilla
1 (3%)
34
Table 3: Results obtained with EchoTip®ProCoretm HD and EchoTip®Ultra HD 22 Gauge
EchoTip®ProCoretmHD 22 G (n=30)
EchoTip® Ultra HD 22 G (n=30)
-minimum
1m 30s
6m
-mean
2m 26s
11m 7s
4m
17m
-easy
22 (73%)
22 (73%)
-difficult
6 (20%)
6 (20%)
-very difficult
2 (7%)
2 (7%)
-easy
22 (73%)*
21 (70%)*
-difficult
7 (24%)*
8 (27%)*
1 (3%)
1 (3%)
-easy
26 (87%)
26 (87%)
-difficult
3 (10%)
3 (10%)
-very difficult
1 (3%)
1 (3%)
Parameter
Time of puncture, (minutes/seconds)
-maximum
Introduction of the needle, n (%)
Exposition of the needle, n (%)
-very difficult
Removal of the needle, n (%)
Similar histological results, n (%)
24 (80%)
24 (80%)
-pancreatic ductal adenocarcinoma
17 (57%)
17 (57%)
-negative for neoplasia
4 (14%)
4 (14%)
-atypical cells
1 (3%)
1 (3%)
-normal pancreatic tissue
1 (3%)
1 (3%)
-inflammatory tissue/pancreatites
1 (3%)
1 (3%)
Different histological results, n (%)
6 (20%)
6 (20%)
-Patient G.S.
pancreatic ductal adenocarcinoma
positive for neoplasia
-Patient M.H.B
-Patient J.L.S
-Patient R.S.J.
negative for neoplasia
suspicious for neoplasia
-Patient I.S.A.
-Patient M.C.P.
neuroendocrine tumor
-sensibility
92%
92%
-specificity
100%*
80%*
-positive predictive value
100%*
95.8%*
-negative predictive value
71.4%*
66.6%*
-accuracy
93.3%*
90%*
Statistical analysis (%)
*There was no statistical difference between the needles (P =1.0)
35
5. COMENTÁRIOS FINAIS:
Os tumores malignos do pâncreas são extremamente letais e a sua real chance de cura
está no diagnóstico precoce (82). Desde o seu surgimento, a ecoendoscopia com punção por
agulha fina permitiu o diagnóstico mais acurado desses tumores, seja pela alta capacidade de
estadiar localmente as lesões, ou por permitir a aquisição de material para o estudo
anatomopatológico destas (100).
Porém, há alguns anos a performance da ecoendoscopia parou de melhorar e não
permitiu uma mudança significativa no manejo dos pacientes com neoplasias pancreáticas.
Para sair desta estagnação, novas técnicas e tecnologias têm sido desenvolvidas nos últimos
10 anos (59, 60, 101-104). Os dois artigos apresentados, dentro de uma linha de pesquisa
voltada especificamente para o diagnóstico ecoendoscópico dos tumores de pâncreas,
experimentou duas dessas novas opções diagnósticas; a citologia em sala realizada pelo
endoscopista (ROSE) e o uso de um novo tipo de agulha (ProCoretm) para realizar as punções
ecoguiadas.
A citologia em sala demonstrou ser uma boa alternativa para melhorar a performance
da punção. Apesar do grupo estudado ter sido de 48 pacientes, isso não foi suficiente para
atingir uma superioridade estatisticamente significante, mas houve uma tendência nítida de
melhora. Alguns estudos prospectivos, já demonstraram isso, porém nenhum no Brasil (85).
No segundo artigo, os autores utilizaram um novo tipo de agulha (EchoTip®ProCoretm HD Wilson Cook, Winston Salem, NC), para puncionar as lesões sólidas do pâncreas. A teórica
vantagem desta agulha é a sua capacidade de conseguir espécimens maiores, com consequente
melhora da performance do método (92). Na casuística apresentada, isso não foi demonstrado.
36
Porém, alguns aspectos devem ser levados em consideração. Só foi realizada uma punção com
o novo modelo de agulha e obteve-se o mesmo resultado, do que 3 punções com a agulha
tradicional. O problema está, provavelmente, na metodologia utilizada, pois comparou-se
números diferentes de passadas no tumor. Porém, quando o protocolo iniciou, o único grupo
que tinha experiência no mundo, com o modelo novo de agulha, padronizou uma só punção,
com várias passadas (59). Já, o número habitual de punções com a agulha tradicional é de 3 a
5. Para que as metodologias de punção fossem iguais, seria necessário realizar uma única
punção com a agulha tradicional que, segundo o próprio artigo publicado por este autor, não
seria ideal para o diagnóstico (37) e, consequentemente antiético.
A outra opção seria realizar 3 punções com a agulha ProCoretm. Nesse caso, o total de
punções ultrapassaria os 5 habituais, podendo incorrer em complicações desnecessárias. Além
disso, como já descrito, a experiência mundial na época em que o estudo iniciou preconizava
a realização de somente 1 punção com este tipo de agulha (59).
Por esses motivo, aplicou-se a metodologia descrita. Também por isso, a punção com
a EchoTip®ProCoretm HD , foi muito mais rápida.
De qualquer maneira, os artigos apresentados, demonstram novas alternativas, com um
potencial não desprezível para melhorar o diagnóstico ecoendoscópico das lesões sólidas
pancreáticas.
Por sinal, ambas as técnicas já foram instituídas na prática diária do grupo de
ecoendoscopia da Santa Casa de São Paulo.
No entanto deve-se enfatizar que, trabalhos multicêntricos, prospectivos e
randomizados são necessários para confirmar ou não os achados dessa linha de pesquisa do
diagnóstico ecoendoscópico das lesões sólidas pancreáticas.
37
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Puli SR, Bechtold ML, Buxbaum JL, Eloubeidi MA. How good is endoscopic
ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid
pancreatic mass?: A meta-analysis and systematic review. Pancreas. [Meta-Analysis
Review]. 2013 Jan;42(1):20-6.
98.
Strand DS, Jeffus SK, Sauer BG, Wang AY, Stelow EB, Shami VM. EUS-guided 22-
gauge fine-needle aspiration versus core biopsy needle in the evaluation of solid pancreatic
neoplasms. Diagn Cytopathol. [Comparative Study
Evaluation Studies]. 2014 Sep;42(9):751-8.
99.
Shi J, Lew M, Zalupski MM, Roh MH, Kwon RS, Pang JC. Implication of suspicious
cytology in endoscopic ultrasound-guided fine-needle aspiration for pancreatic cancer. J
Gastrointest Cancer2015 Mar;46(1):54-9.
100.
Hasan MK, Hawes RH. EUS-guided FNA of solid pancreas tumors. Gastrointest
Endosc Clin N Am. [Review]. 2012 Apr;22(2):155-67, vii.
101.
Konda VJ, Aslanian HR, Wallace MB, Siddiqui UD, Hart J, Waxman I. First
assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of
the pancreas (with videos). Gastrointest Endosc. [Multicenter Study
Video-Audio Media]. 2011 Nov;74(5):1049-60.
102.
Bhutani M, Koduru P, Lanke G, Bruno M, Maitra A, Giovannini M. The emerging
role of endoscopic ultrasound-guided core biopsy for the evaluation of solid pancreatic
masses. Minerva Gastroenterol Dietol2015 Jun;61(2):51-9.
103.
Giovannini M. Endoscopic ultrasound elastography. Pancreatology2011;11 Suppl
2:34-9.
104.
Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J,
Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea
51
DI, Ciurea T. Accuracy of endoscopic ultrasound elastography used for differential diagnosis
of focal pancreatic masses: a multicenter study. Endoscopy. [Clinical Trial
Multicenter Study]. 2011 Jul;43(7):596-603.
52
7. ANEXOS:
7.1 APROVAÇÕES NO COMITÊ DE ÉTICA
Artigo 1
53
Artigo 2.
54
7.2. NORMAS PARA PUBLICAÇÃO
7.2.1 ACTA CIRÚRGICA BRASILEIRA
Acta Cir. Bras. - Instruções aos autores 04/10/15 22:19
http://www.scielo.br/revistas/acb/pinstruc.htm Página 1 de 5
ISSN 0102-8650 versão impressa
ISSN 1678-2674 versão online
INSTRUÇÕES AOS AUTORES
Objetivo e política editorial
Preparação dos manuscritos
Objetivo e política editorial
A Revista Acta Cirúrgica Brasileira tem um padrão, estilo, regras e
normas que devem ser cumpridas. Seguir as Instruções aos Autores em
www.scielo.br/acb (português/inglês). Observar os modelos nos artigos
publicados. Revisão acurada do manuscrito antes de enviar, pois se não
cumprir as instruções, não será aceito.
A Revista Acta Cirúrgica Brasileira cumpre as normas do International
Committee of Medical Journal Editors: Ethical Considerations in the
Conduct and Reporting of Research, Authorship and Contributorship
(www.icmje.org).
Autoria
A Revista Acta Cirúrgica Brasileira considera todos os participantes do
artigo como autores. Autores são considerados aqueles que têm efetiva
contribuição intelectual e científica na realização do trabalho. Não é papel
do editor, arbitrar conflitos relacionados à autoria.
O autor principal é o responsável pela integridade do artigo, como um
todo, não necessariamente ser o primeiro autor, entretanto deve ser o
autor correspondente. A Revista não aceita alunos de graduação e
pós-graduação como autores principais. O autor principal assume a
responsabilidade pela participação efetiva de cada autor e pela
concordância com o conteúdo do artigo.
Participantes que tiveram atividade puramente técnica (ato operatório,
revisão bibliográfica, chefes de departamento, serviços ou financiados)
devem ser listados nos agradecimentos.
Contribuição dos autores
Cada autor deve assumir a responsabilidade de pelo menos um
componente do trabalho:
1. Contribuição científica e intelectual efetiva para o estudo;
2. Concepção e delineamento;
3. Aquisição dos dados;
4. Interpretação dos dados;
5. Procedimentos técnicos;
6. Exames macroscópicos e histopatológicos;
7. Análise estatística;
8. Preparação do manuscrito;
9. Redação do manuscrito;
10. Revisão crítica;
55
11. Aprovação final.
Tipos de Publicação
Os Suplementos da revista podem ter objetivos úteis para cooperação
entre Instituições Acadêmicas. O Editor Chefe terá a autoridade de enviar
os suplementos para apreciação de pareceristas que poderão rejeitar
artigos. É fundamental distinguir nas referências os artigos de
suplementos e os da publicação regular.
A revista aceita artigos de pesquisa, preferencialmente de cirurgia
experimental, investigação clínica e de revisão solicitada pelo Corpo
Editorial.
Revisões sistemáticas e metanálises enfocando temas cirúrgicos de
interesse atual serão consideradas para publicação. Todas as metanálises
de ensaios randomizados deverão atender os princípios do QUORUM
(Lancet. 1999;354:1896-1900) e o manuscrito submetido deverá conter
o fluxograma detalhado da revisão sistemática.
A Revista não aceita relato de caso ou de casos e trabalhos
retrospectivos.
Fluxograma do manuscrito
Os manuscritos submetidos pelos autores à Acta Cirúrgica Brasileira
serão inicialmente avaliados pelo Editor Chefe, quanto aos objetivos e
padrão da revista. Nesta fase, o manuscrito poderá ser devolvido ao
autor para adequações ou rejeitado. Caso o manuscrito esteja de acordo
com as normas, será encaminhado ao Editor Associado, que designará os
Pareceristas para avaliação do conteúdo científico. O Editor Associado ao
receber os pareceres, os encaminhará ao Editor Chefe para a decisão
final. O fluxo poderá ser acompanhado pelo autor no sistema de
gerenciamento.
Preparação dos manuscritos
O texto e o abstract devem ser revistos por especialistas da área médica,
habituados com a redação científica do idioma. O documento principal
(Main document), em inglês, deve conter a página inicial (Title Page), as
figuras com as legendas e as tabelas com os enunciados, além do
manuscrito.
Página inicial
O título do artigo deve ser conciso, mas informativo. Inserir o número
um (algarismo arábico), sobrescrito, indicando após as referências o local
da realização da pesquisa (laboratório, centro de pesquisa, disciplina,
departamento e instituição). Não incluir siglas.
Afiliação de cada autor: O nome completo de todos os autores com os
números subsequentes sobrescritos (algarismo romano) que indicarão a
categoria acadêmica mais elevada de cada um, com o nome da
disciplina/departamento e da instituição. Informar se tem bolsa de
pesquisador do CNPq e respectivo nível.
Alunos em nível de Mestrado e Doutorado devem referir o nome do
Programa de Pós-Graduação, conforme a CAPES. Podem ser considerados
como primeiro autor e o Professor Orientador/Tutor como autor
correspondente.
Alunos de graduação são bem-vindos. É desejável que tenham Bolsa de
56
Iniciação Científica (PIBIC-CNPq, IC-FAPESP, Institucional ou outras
agências).
Observar os títulos acadêmicos no idioma inglês. Consultar Acta Cir
Bras. 2006;21(2):60 Mar-Abr. Academic degrees examples
ABSTRACT
Não deve exceder 200 palavras e deve ser apresentado de forma
estruturada:
PURPOSE (claro, preciso e conciso, sem comentários)
METHODS (amostra e procedimentos)
RESULTS (principais achados com dados especificados e significância
estatística)
CONCLUSION (clara, precisa e concisa, respondendo o objetivo, sem
comentários).
Key words devem constar no DeCS/MeSH. Acessar http://decs.bvs.br.
Termos que não fazem parte do DeCS impedem a localização do artigo.
Estrutura do manuscrito
Introdução
Introdução
Deve apresentar o estado atual do tema e oferecer somente citações
pertinentes, sem fazer revisão extensa do assunto. Autores devem ser
apresentados em letras minúsculas ou simplesmente citados por números
sobrescritos, sem o ano do artigo.
Métodos
Deve apresentar a amostragem (quantidade e qualidade) e os
procedimentos em pormenores suficientes que permitam a outros
pesquisadores reproduzirem os resultados. Identificar, precisamente,
todas as drogas, substâncias químicas e produtos utilizados, incluindo os
nomes genéricos, dosagens e formas de administração. Não referir
nomes de pacientes, iniciais ou número do protocolo hospitalar.
Descrever os métodos estatísticos com pormenor e fornecer referências
para os procedimentos consagrados. O autor principal é responsável pela
exatidão dos dados, incluindo todos os cálculos estatísticos.
Ética
A investigação em seres humanos deve ser submetida ao Comitê de Ética
da Instituição (preencher o número do processo), cumprindo a
Declaração de Helsinki de 1975, revisada em 2008
(www.wma.net/e/policy/b3.htm) e a Resolução 466/12 do Conselho
Nacional de Saúde
(http://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf)
A investigação em animais deve ser submetida à Comissão de Ética no
Uso de Animais (CEUA). Preencher o número do processo de aprovação
da pesquisa, cumprindo a Lei Federal nº 11.794, de 8 de outubro de
2008 (http://www.planalto.gov.br/ccivil_03/_Ato20072010/2008/Lei/L11794.htm) e o Decreto nº 6.689, de 15 de julho de
2009 que regulamenta a Lei nº 11.794
(http://www.planalto.gov.br/ccivil_03/_Ato20072010/2009/Decreto/D6899.htm).
Artigos de autores estrangeiros devem seguir o Council for International
57
Organization of Medical Sciences (CIOMS)
http://www.cioms.ch/index.php/12-newsflash/227-cioms-and-iclasreleasethe-new-international-guiding-principles-for-biomedical-researchinvolvinganimals
O Corpo Editorial da Revista poderá recusar artigos que não cumpram
rigorosamente os preceitos éticos da pesquisa.
Resultados
No texto enfatizar as observações importantes. Incluir os dados de
significância estatística.
Tabelas: são abertas e numeradas consecutivamente (algarismos
arábicos) e apresentar um título breve, colocado acima. Utilizar
abreviaturas aprovadas e padronizadas. As abreviaturas não
padronizadas devem ser explicadas em notas de rodapé da tabela. Não
deve ter linhas verticais.
Quadros: são fechados, com dados descritivos e apresentar um título
breve, colocado acima.
Figuras [Ilustrações, fotografias e gráficos]: devem ser de boa qualidade.
Não repetir no texto todos os dados constantes das tabelas e figuras. As
figuras também devem ser numeradas sequencialmente em algarismos
arábicos. As legendas devem aparecer abaixo da figura.
Discussão
Enfatizar os aspectos novos e relevantes do estudo. Comparar os
métodos e resultados com os anteriormente publicados. Cotejo entre as
observações próprias com a de outros autores. Não repetir resultados.
Conclusão
Deve ser clara e concisa e responder aos objetivos do estudo. Evitar
comentários e repetição de dados.
Referências
As referências devem ser atualizadas, selecionadas e utilizadas as mais
importantes pertinentes à pesquisa, publicadas em periódico indexado.
Serão aceitas, no máximo, 30 referências por artigo.
Devem ser cumpridas as normas de Vancouver (www.icmje.org). Além
disso, conforme determinação do SciELO, é necessária a inclusão do doi
ou PMID (PubMed). Os títulos dos periódicos devem ser abreviados de
acordo com o estilo usado no MEDLINE/PubMed.
As referências devem ser numeradas consecutivamente na ordem em
que foram mencionadas a primeira vez no texto. Devem ser incluídos os
nomes de todos os autores (et al. não é aceito). Não são aceitas
referências a resumos, comunicação pessoal ou qualquer outra fonte não
indexada (livros texto e teses).
O Editor leva em consideração a seriedade e o apuro nas referências,
sendo tão importantes quanto a própria pesquisa.
Exemplos de referências
Fogarty BJ, Parks RW, Rowlands BJ, Diamond T. Renal dysfunction in
obstructive jaundice. Br J Surg. 1995 Jul;82(7):877-84. PMID:
7648096.
Fickert P, Krones E, Pollheimer MJ, Thueringer A, Moustafa T, Silbert D,
Halilbasic E, Yang M, Jaeschke H, Stokman G, Wells RG, Eller K,
58
Rosenkranz AR, Eggertsen G, Wagner CA, Langner C, Denk H, Trauner M.
Bile acids trigger cholemic nephropathy in common bile-duct-ligated
mice. Hepatology. 2013 Dec;58(6):2056-69. doi: 10.1002/hep.26599.
Agradecimentos
Reconhecer aqueles que contribuíram para o trabalho, mas sem
possuírem as características de autores.
Correspondência
Nome completo do autor principal, endereço, telefones e e-mail.
Declaração
Conflito de interesse e fonte de financiamento.
Declaração do conflito de interesse, a fim de cumprir a Resolução do
Conselho Federal de Medicina n.1595/2000, que veda artigos, mensagens
e materiais promocionais de produtos ou equipamentos de uso na área
médica.
No final do manuscrito, mencionar o local da realização da pesquisa:
laboratório/centro de pesquisa, disciplina, departamento e instituição.
Se for aluno de Programa de Pós-graduação, informar se o artigo é parte
de tese (nível mestrado, doutorado ou pós-doutorado) e nome do
Professor Orientador/Tutor/Supervisor.
Exemplo: 1Research performed at Laboratory of Experimental Surgery,
Department of Surgery and Liver Transplantation, Federal University of
Parana (UFPR), Curitiba-PR, Brazil. Part of Master degree thesis,
Postgraduate Program in Surgical Clinic. Tutor: Jorge Eduardo Fouto
Matias
Direitos autorais
Os autores cujos trabalhos forem aceitos para publicação transferem
todos os direitos de reprodução (copyright) a Acta Cirúrgica Brasileira, de
acordo com o Ato de Direitos Autorais de 1976. Uma carta contendo essa
declaração deve ser encaminhada junto com o artigo, assinada pelo autor
principal/correspondente, responsável pelo artigo como um todo, em
nome de todos os autores.
Exemplo:
"O autor abaixo assinado transfere todos os direitos autorais do artigo
intitulado "_____________________" à Acta Cirúrgica Brasileira.
Garante que o artigo é original, não infringe qualquer direito autoral ou
direito à propriedade de terceiros, não está em avaliação por outro
direito à propriedade de terceiros, não está em avaliação por outro
periódico e não foi previamente publicado. O trabalho foi lido e cada um
dos autores confirma sua contribuição".
Nome legível e assinatura
Taxa de publicação
Os autores devem compartilhar os custos da edição. Depositar o valor de
R$800,00 no Banco do Brasil - Ag.1898-8 Conta corrente:9161-8 em
nome da SOBRADPEC - CNPJ 57.860.488/0001-44. Comunicar por e-mail
([email protected]) confirmação do depósito identificando o
remetente.
Submissão online
Os artigos devem ser enviados por meio do sistema eletrônico de
59
gerenciamento no endereço: https://mc04.manuscriptcentral.com/acbscielo.
Dúvidas/esclarecimentos entrar em contato com Prof. Saul Goldenberg
[email protected]
[Home] [Sobre a revista] [Corpo editorial] [Assinaturas]
Todo o conteúdo do periódico, exceto onde está identificado, está licenciado sob uma Licença
Creative
Commons
Al. Rio Claro, 179/141 - 14º and.
01332-010 São Paulo SP Brasil
Tel./Fax: +55 11 3287-8814
[email protected]
60
7.2.2 SURGICAL ENDOSCOPY
SURGICAL ENDOSCOPY
INSTRUCTIONS FOR AUTHORS
PLEASE NOTE:
EFFECTIVE APRIL 9, 2015 (OFFICIAL CONFLICT OF INTEREST
DISCLOSURE STATEMENTS AND FORMS):
All potential benefits in any form from a commercial party
related directly or indirectly to the subject of this
manuscript or any of the authors must be acknowledged. For
each source of funds, both the research funder and the grant
number should be given.
For Surgical Endoscopy this is a
two-step process:
Author Disclosures within the submitted manuscript.
The Disclosures section should appear in the manuscript as a
separate section immediately before the references. The
Disclosure section is required for submission. If it is not in
the manuscript, the submission will be returned for correction
before review. If the authors have nothing to disclose, state
this in the section for each author, listing each author by
name.
The
Disclosure
section
should
include
all
corporate/commercial relationships that might pose a conflict
of interest, e.g., all of the authors’ relationships with all
pharmaceutical or device companies. This includes such things
as all consultantships, honoraria, stock ownership, gifts,
free or reimbursed travel/ vacations, equity interests,
arrangements regarding patents or other vested interests, etc.
(not just those immediately related to this specific paper or
to the pharmaceutical or device company sponsoring the
submitted paper). If a specific author has no financial
relationships with any pharmaceutical or device company, it
must be so stated in the Disclosure section.
When preparing the Author Disclosure, make sure to list
all authors by name. Also, make sure to use the
following format for authors who have nothing to
disclose: “Drs. A, B, and C have no conflicts of
interest or financial ties to disclose.”
Here is an
example of a disclosure statement: Dr. A has an equity
interest in. . . . Dr. B is on the speakers’ bureau of. . . .
Drs. C, D. and E have no conflicts of interest or financial
ties to disclose.
61
Conflict of Interest forms with submission. As part of
the submission process you must upload a completed and signed
ICMJE disclosure form for each author. Manuscripts submitted
without all forms will be returned for corrections. Blank
ICMJE
forms
are
available
for
download
at
http://www.icmje.org/.
MANUSCRIPT SUBMISSION TYPES AND PEER REVIEW
All manuscripts submitted to Surgical Endoscopy must be
original; i.e. not published elsewhere (except in abstract
form) and not under consideration for publication elsewhere.
Surgical
Endoscopy
will
consider
manuscripts
prepared
according to the instructions below. Manuscripts that deviate
from the instructions will be sent back for correction before
peer review.
The Editors-in-Chief invite submissions that fall into the
following categories of manuscripts:
1. Randomized controlled clinical studies
2. Prospective case-controlled studies
3. Retrospective case-controlled studies
4. Substantive retrospective series
5. Technology papers: describing new technologies and their
evaluation.
Any such manuscripts must have data on the
benefits, efficacy and or safety of the technology,
experimental or clinical as appropriate
6. Review articles: based on exhaustive literature search
with description of the methods used in the literature
search.
7. Meta-analysis of published RCTs – These manuscripts must
clearly indicate that statistical expertise was available
to the authors.
8. Technical notes: concern descriptions of new surgical
techniques
relating
to
laparoscopic
or
flexible
endoscopic surgery.
These short reports must contain a
brief clinical or experimental account of their use.
9. Videos and dynamic manuscripts.
Surgical Endoscopy does not accept case reports and all
retrospective series submitted to the journal must be
on a cohort of 10 or more patients.
Surgical Endoscopy no longer considers Letters to the
Editor for publication in the journal. If you are
writing a letter because you feel that authors of a
paper
have
plagiarized
the
paper,
distorted
or
embellished their work, or published the same work in
more than one journal, please send your remarks in an
62
email directly to both Editors-in-Chief: Dr. Mark
Talamini (mark.talamini
@stonybrookmedicine.edu)
and
Professor
Sir
Alfred
Cuschieri ([email protected]).
All manuscripts submitted to Surgical Endoscopy are subject to
peer review and editing. Each substantive manuscript is
reviewed by at least two experts in the field, who may also be
members of the Editorial Board. The decision of the Editorsin-Chief is final. The authors are notified of the decision by
e-mail, with reviewer comments, if applicable. The reviewers
of the journal are recruited from the various disciplines
related to endoscopic surgery and allied technologies and
interventions and also from members of the two affiliated
societies, EAES and SAGES.
If you would like to receive language editing by a scientific
expert prior to manuscript submission, Springer recommends
using Edanz Group. Edanz provides scientific editing and
related services that raise the quality of manuscripts to the
standard necessary for ease of peer review. As the only
international editing service centralized in China and Japan,
Edanz understands the publication challenges faced by
scientists worldwide, whose first language is not English. For
more information and a price quotation, please contact:
http://www.edanzediting.com/springer
CONSORT (Consolidated Standards of Reporting Trials)
For Information on the most updated Consort Statement and to
download the Consort E-Checklist and the E-flowchart, go to:
www.consort-statement.org
Experimental Subjects/Animals
All authors are expected to abide by accepted ethical
standards.
In investigations that involve human subjects or
laboratory animals, authors should provide an explicit
statement in Materials and Methods that the experimental
protocols were approved by the appropriate institutional
review committee and meet the guidelines of their responsible
governmental agency. In the case of human subjects, informed
consent is essential.
All randomized controlled clinical
trials
(RCTs)
should
conform
to
the
CONSORT
criteria
(http://www.biomedcentral.com/1471-2288/1/2).
The
corresponding author should indicate whether the RCT has been
registered or not.
Clinical Trial Registration
63
All trials must be registered in a public trials registry that
is acceptable to the International Committee of Medical
Journals Editors (ICMJE). (http://www.icmje.org/faq.pdf).
REQUIRED FORMS
Official Conflict of Interest Disclosure Form
See explanation above.
Permissions
If a figure or a table has previously appeared in copyrighted
material, or if extensive material is quoted, the author must
obtain written permission from the copyright holder (usually
the publisher, not the author, of the original work) to
reprint it.
Full credit to the original publication must be
included in the legend of the figure or footnote to the table.
Provide all letters granting permission at the time of
submission of the manuscript.
The author is responsible for
payment of applicable fees for reprinting previously published
material.
The use of photographs that identify patients
requires a written release form from the patient (or guardian)
to
do
so.
Obtaining
this
release
is
the
author’s
responsibility and a copy of the release must accompany the
manuscript at the time of submission.
Copyright Transfer Statement
Effective February 23, 2012:
Copyright forms are now
handled
online
after
the
manuscript
is
accepted
for
publication. Please see the “AFTER ACCEPTANCE: MyPublication”
section below for more information.
ONLINE SUBMISSION REQUIREMENTS VIA EDITORIAL MANAGER
Manuscripts are submitted online to Surgical Endoscopy via
Editorial Manager. Please log directly onto the site at
http://www.editorialmanager.com/send/
and
submit
your
manuscript following the instructions given on the screen.
User Accounts
Authors entering the Surgical Endoscopy Editorial Manager site
should use their existing account if they have one. When you
have an existing account, use it for all your submissions and
you can track their status on the same page. If you are unsure
about whether or not you have an account, or have forgotten your password,
click on “Login Help” on the first screen. Otherwise please create a
new account and then follow the instructions given on the
screen.
64
Getting Started
Once you have logged into your account, Editorial Manager will
lead you through the submission process in a step-by-step
orderly process. If you cannot finish your submission in one
visit, you can save a draft and re-enter the process at the
same point for that manuscript. While submitting your
manuscript online, you will be required to enter data about
your manuscript in the system. These include title, names of
all authors, institutions with full address, correct email
address for all authors, and address of author to whom
correspondence should be sent, and so forth as listed below
under “MANUSCRIPT PREPARATION”. Support for special characters
is available. At any point during this process, there are help
buttons available to see common questions and a support link
to ask a specific question via e-mail.
Preparing Electronic Files for Submission
After entering all the information about manuscript title,
abstract, authors and other details, you will be prompted for
uploading files. Please, follow the instructions below for
preparation of suitable electronic files. For review purposes,
your text and figure file(s) will be converted into a PDF
document so it can be viewed and printed with Adobe Acrobat
Reader. The files in the PDF document will be presented in the
order specified.
The main document with manuscript text and tables should be
prepared with an electronic word processing program. Please,
do NOT include figures or illustrations within the manuscript
text file.
Save each figure as a single image file in either uncompressed
TIFF, GIF, JPEG, or EPS format. Please refer to the
“GUIDELINES FOR ELECTRONICALLY PRODUCED FIGURES” below for
details on how to produce high quality electronic figures.
Images created in slide presentation programs, such as
Microsoft PowerPoint, are low resolution and NOT acceptable.
Charts created with Microsoft Excel are NOT acceptable. Please
verify your uploaded files before proceeding with your
submission.
You will be notified by email that your submission was
successful. Successful submission does not mean that your
paper is accepted for peer review. Keep copies of your wordprocessing and figure files. After submission, you may return
65
periodically and monitor the
through the review process.
progress
of
your
submission
If you have any questions while submitting,
contact the coordinating editorial office:
please
Bernadine Richey
Coordinating Editorial Office, Surgical Endoscopy
117 Lexow Avenue
Upper Nyack, NY 10960, USA
Tel: (845) 353-3106
Fax: (845) 348-3948
E-mail: [email protected]
MANUSCRIPT PREPARATION
Manuscripts must be clearly and concisely written in English,
and authors are urged to aim for clarity, brevity, and
accuracy of information and language. Authors whose first
language is not English should enlist the help of colleagues
who are proficient in scientific English or a language editing
service. Manuscripts should be submitted in their final form.
The position of figures and tables should be indicated in the
text.
MANUSCRIPTS THAT DO NOT FOLLOW THE INSTRUCTIONS LISTED
HERE WILL BE RETURNED FOR CORRECTION BEFORE BEING
REVIEWED.
All manuscripts should be prepared as follows:
Title Page:
• Full title of manuscript
• A short running head of not more than 40 characters
• The first and last names of each author with highest
academic degree, and the department and institutional
affiliation for each author. All authors must meet the
criteria for authorship in the Consensus Statement
on
Journal
Authorship
cited
later
in
these
instructions.
• The name, address, telephone, fax, and email of the
author to whom correspondence during the review process
should be addressed.
• The name, address, telephone, fax, and email of the
author to whom correspondence after publication should be
addressed (if different than above).
66
•
Funding information specific to this paper. For each
source of funds, both the research funder and the grant
number should be given.
Please note: The Corresponding author should carefully
check
the
names
and
order
of
all
authors
when
submitting a manuscript. Additions or deletions of
authors or changes to the order of authors cannot be
made after an article has been accepted.
Abstract and Key Words:
• Structured Abstract of not more than 300 words stating
Background, Methods, Results, and Conclusions
• List up to six key words.
Text:
Text should be arranged in the order of Introduction,
Materials and Methods, Results, Discussion, Acknowledgments,
Disclosures, References
Acknowledgments: Acknowledgments of people should appear in
this section if needed.
Disclosures: Disclosures are required for each author to be
included within the manuscript text. Each statement must
include the author’s name and declare the conflict of
interest, or “no conflict of interest”. All potential benefits
in any form from a commercial party related directly or
indirectly to the subject of the manuscript or any of the
authors must be acknowledged. For each source of funds, both
the funding organization (written in full) and the grant
number should be given. Please note that the manuscript will
be returned to the corresponding author if the disclosure
statement for each author is not included in the manuscript
text. Details provided in the disclosure statement must
correspond with the information provided in the COI forms
uploaded during submission.
References:
The author is responsible for the accuracy of the references.
Citations in the text should be identified by numbers in
brackets. The in-text references and the reference list at the
end of the manuscript should be in citation order. Only
published works and/or already accepted manuscripts for
publication can be included. Please see the following samples
on how to list the references correctly:
a) Articles from journals: Name(s) and initials of ALL
author(s), year in parentheses, full title, journal name as
67
abbreviated in Index Medicus, volume followed by a colon,
first and last page numbers.
Berci G, Paz-Paltrow M (1988) Electronic imaging in
endoscopy. Surg Endosc 2:227-233
b) Articles from electronic publications: Name(s) and
initials of ALL author(s), year in parentheses, full title,
journal name as abbreviated in PubMed. DOI number, and
publication date.
With DOI number:
Duffy PE, Awad ZT, Filipi CJ (2003) The laparoscopic
reoperation of failed Heller myotomy. Surg Endosc, DOI:
10.1007/s00464–002–8570-y, May 7, 2003.
Without DOI number:
Bates D (2002) The quality case for information technology
in healthcare. Available at: http://www.biomedcentral.com/
1472–6947/2/7. October 2002; Accessed 19 December 2002.
c) Books: Name(s) and initials of ALL author(s), year in
parentheses,
title,
edition,
publisher,
place
of
publication.
Roy C (1988) Ultrasound of the abdomen (exercises in
radiological
diagnosis)
Springer,
Berlin
d) Multiauthor books: Name(s) and initials of ALL author(s),
year in parentheses, title of the paper. In: name(s) and
initials of all editor(s), title of book, publisher, places
of
publication,
first
and
last
page
numbers.
White, ME, Choyke PL (1988) Duplex sonography of the
abdomen. In: Grant EG, White EM (eds) Duplex sonography,
Springer, New York, pp 129-190
e)
Multimedia
Manuscripts:
Holcomb
III
GW.
(2003)
Laparoscopic fundoplication in an infant. Surg Endosc, DOI:
10. 1007/s 00464–003–6000-y 17: 1319
For authors using EndNote, Springer provides an output style that supports the formatting of in-text citations and
reference list.
Tables:
• All tables are to be numbered using Arabic numerals
• Tables should always be cited in text in consecutive
numerical order
• For each table, please supply a table title.
• The table title should explain clearly and concisely
the components of the table
68
•
•
Identify any previously published material by giving
the original source in the form of a reference at the
end of the table title.
Footnotes
to
tables
should
be
indicated
by
superscript lower-case letters (or asterisks for
significance values and other statistical data) and
included beneath the table body
Figures: Figures should be limited to those essential for the
text. The same results should be presented as either figures
or tables, not as both. Color can be used without charge for
the online version of the journal but will appear in the
printed version of the journal at the author’s expense at USD
$1150 per article. The corresponding author can purchase color
for print during the “MyPublication” stage after the paper is
accepted and exported to publisher. All figures, whether
photographs, graphs, or diagrams, should be numbered
consecutively and cited within the text, and uploaded
into Editorial Manager as individual figures separately
from the text. Please see the “GUIDELINES FOR ELECTRONICALLY
PRODUCED FIGURES” below for acceptable figure format. All
figures submitted should allow for high quality reproduction.
The publisher reserves the right to reduce or enlarge figures.
Arrows,
letters,
and
numbers
should
be
inserted
professionally.
Micrographs
should
have
an
internal
magnification marker; the magnification should also be stated
in the legend.
Figure Legends:
Legends must be brief, self-sufficient
explanations of the figures in no more than four or five
lines. Remarks such as “For explanation, see text” should be
avoided. Figure legends are considered text and should
appear in your main document.
GUIDELINES FOR ELECTRONICALLY PRODUCED FILES
Figures/Illustrations
•
•
•
•
•
•
All figures are to be numbered using Arabic numerals
Figure parts should be denoted by lowercase letters
Figures should always be cited in text in consecutive numerical order
For each figure, please supply a figure legend
Make sure to identify all elements found in the figure in the figure
legend
Identify any previously published material by giving the original
source in the form of a reference at the end of the figure legend
Additional instructions for preparing your illustrations can
be found at
69
(http://www.springer.com/authors/manuscript+guidelines?SGWID=0
-40162-12-331200-0)
Videos
Videos are submissions where the essence of the article is the
video.
An abstract is required so that the submission is
indexed in PubMed. As with text submissions, case reports are
not encouraged unless they are very unusual or timely.
Authors are strongly encouraged to include case series
information on the video with attention to clinical outcomes.
Multimedia as a format to convey other types of information
will be considered on a case by case basis.
Requirements:
• Choose “Video” as the manuscript type.
• The video should not exceed 9 minutes.
• An audio narration in English must accompany the video.
• The maximum size for all files (including videos) in the
submission is 350 MB. Videos must be in one the following
formats: MPEG-1, QuickTime or WMV. The video file must be
playable on a Windows-based computer.
• No music sound tracks.
• Avoid "fancy" video transitions.
• Annotation of anatomic structures is encouraged.
• No authored DVDs.
• There should be a “manuscript” submitted with the video
that includes a title page, abstract, and disclosures, as
well as references if needed.
Dynamic Manuscripts
A dynamic manuscript is a print article with imbedded video
material that is accessed online. Up to 4
video clips per
manuscript submission can be submitted. Dynamic manuscripts
are submitted as regular text articles with short video clips
included that will play when the hyperlink is selected when
viewing the full text online. The dynamic manuscript is a
perfect opportunity for authors to supplement the text
submission with short multimedia clips that augment, enhance,
or highlight key concepts within the manuscript. Examples of
this could include: a fluoroscopy cholangiogram; video
endoscopic findings; short intraoperative video segment;
narrated examination of the microscopic histologic findings;
physical examination; or animated graphics that replace the
static graphic that appears in the print manuscript. Authors
are encouraged to be creative.
Requirements
• Choose “Dynamic/Multimedia Manuscript” as the manuscript
type.
70
•
•
•
•
•
•
•
•
•
All standard instructions for both manuscript and video
submission should be followed.
Video clips should not exceed 4 clips in the submission.
A narration in English must accompany the video.
The maximum size for all files (including videos) in the
submission 350 MB. Videos must be in one the following
formats: MPEG-1, QuickTime, or WMV. The video file must
be playable on a Windows-based computer.
No music sound tracks.
Avoid "fancy" video transitions.
Annotation of anatomic structures is encouraged.
No authored DVDs.
Make sure to note in your manuscript the placement of the
short video clips. You may replace a static image from
the print version with a video for the electronic
version.
AFTER ACCEPTANCE
MyPublication
Upon acceptance of your manuscript, the corresponding author
will receive an email with a link directing them to an online
workflow called MyPublication.
MyPublication allows the
corresponding author to easily manage all author-related tasks
during the publishing process.
Through MyPublication, the
corresponding author will be asked to complete a series of
author-related
tasks
including
(1)
option
to
purchase
offprints/reprints of the article, (2) option to purchase and
produce color figures in the print issue, and (3) option to
publish the article as Open Access via Springer’s Open Choice
program. PLEASE NOTE: THE CORRESPONDING AUTHOR WILL NOT
RECEIVE PROOFS OF THE ARTICLE UNTIL THE MYPUBLICATION
STAGE HAS BEEN COMPLETED.
For more information about
MyPublication,
please
go
to:
http://www.springer.com/authors/journal+authors?SGWID=0154202-12-417699-0
(1) Copyright Transfer Statement: The corresponding author
(on behalf of all co-authors) will be asked to transfer
copyright of the article to the Publisher (or grant the
Publisher exclusive publication and dissemination rights).
This will ensure the widest possible protection and
dissemination of information under copyright laws. Articles
published as Open Access via Springer’s Open Choice program
(see below) do not require transfer of copyright as the
copyright remains with the author.
71
(2) Offprints/Reprints: The corresponding author will have
the option to purchase article offprints/reprints. Delivery
of the offprints/reprints are made upon publication of the
article in a print issue.
(3) Color in Print: Online publication of color illustrations
is free of charge. For color in the print version, the
corresponding author will have the option to purchase color.
(4) Springer Open Choice: In addition to the traditional
publication process (whereby an article is submitted to the
journal and access to that article is granted to customers
who have purchased a subscription), authors can choose to
publish their article as Open Access via Springer’s Open
Choice program.
If you choose to publish your article as
open access within the Springer Open Choice program, the
copyright will remain with the authors and the article will
be published under the Creative Commons AttributionNoncommercial License. We regret that Springer Open Choice
cannot be ordered for published articles. Please go to:
http://springer.com/openchoice or click on the below link
for more information.
Click the following link for more
information about Open Choice:
http://www.springer.com/open+access/open+choice?SGWID=040359-0-0-0
Author Proofs
After a manuscript is accepted, typeset, and processed through
production, a proof of the article is made available to the
corresponding author. The corresponding author is responsible
for proofreading the proof and to check for typesetting errors
and the completeness and accuracy of the text, tables and
figures on behalf of all the authors. Substantial changes in
content, e.g., new results, corrected values, title and
authorship, are not allowed without the approval of the
Editors-in-Chief.
The corresponding author can return
corrections to the proof via online, email, or fax.
PLEASE
NOTE THAT THIS IS THE ONLY PROOF THE CORRESPONDING
AUTHOR WILL RECEIVE.
The article will be published online
after the author corrections are made. The online publication
date is the official date of publication. The online version
of the article is fully citable with the Digital Object
Identifier (DOI). The selection of your article to appear in
an issue is under the discretion of the Editor. The article
can also be cited by issue and page numbers after it is
assigned and published in an issue.
Once the article is
published online, further changes can only be made in
the form of an Erratum, which will be hyperlinked to
the article. Authors can track the progress of their article
from the time of acceptance to print publication by creating a
Springer
account
at
72
https://www.springer.com/my+springer?SGWID=4-1716000-25653405-0.
CONSENSUS
STATEMENT
MANUSCRIPTS
ON
SUBMISSION
AND
PUBLICATION
OF
(Published in the June 2001 issue of Surgical Endoscopy, page
537)
Increasing problems of duplicate and fraudulent submissions
and publications have prompted the editors of surgical
journals, including Surgical Endoscopy, to support these
overall
principles
of
publication:
Duplicate Submission and Publication
In general, if a manuscript has been
published,
any
subsequent
publication
Exceptions to this general rule may be:
peer-reviewed and
is
duplication.
a) Prior publication in meeting program abstract booklets or
expanded abstracts such as those published by the
Surgical Forum of the American College of Surgeons or
Transplantation Proceedings. However, these must be
referenced in the final manuscript.
b) A manuscript which extends an original database (a good
rule might be expansion by 50% or more) or which analyzes
the original database in a different way in order to
prove or disprove a different hypothesis. Previous
manuscripts
reporting
the
original
database
must,
however, be referenced.
c) Manuscripts which have been published originally in nonEnglish language journals, provided that the prior
publication is clearly indicated on the English language
submission and referenced in the manuscript. In some
circumstances, permission to publish may need to be
obtained from the non-English language journal.
For example, any submission duplicating material previously
published in full in "Proceedings" or book chapters is
considered duplicate unless the exceptions in (a) above apply.
Similarly, manuscripts dealing with subgroups of data (i.e.,
patients) that have previously been analyzed, discussed and
published as a larger group are considered duplicate unless
(b) above applies.
The Internet raises special concerns. If data have previously
appeared on the Internet, submission of those data for
publication is considered duplication. If Internet publication
follows journal publication, the journal publication should be
clearly referenced. Some journals may provide early Internet
73
publication of accepted peer reviewed papers which are
subsequently published in that journal. This does not
constitute duplication if both manuscripts are identical and
covered by the same single copyright.
Fraudulent Publication
The
following
activities
are
examples
of
fraudulent
publication practices:
• Willful and knowing submissions of false data for
publication.
• Submission of data from sources not the author's (or
authors') own.
• Falsely certifying that the submitted work is original
and has not been submitted to, or accepted by, another
journal.
• Sponsoring or vouching for a manuscript containing data
over which the sponsor has no control or knowledge.
• Allowing one's name to appear as an author without having
contributed significantly to the study.
• Adding an author's name to a manuscript to which he/she
has not contributed, or reviewed or agreed to in its
current form.
• Flagrant omission of reference to the work of other
investigators which established their priority.
• Falsification of any item on the copyright form.
• Failure to disclose potential conflict of interest with a
sponsoring agency.
While not intended as an all-inclusive document, these
examples and guidelines should alert authors to potential
problems that should be avoided when they are considering
submission of a manuscript to a peer-reviewed journal.
In the majority of clinical and research studies submitted to surgery
journals for possible publication, many individuals participate in the
conception, execution, and documentation of each of those works. However,
recognition of work in the form of authorship has varied widely. This
consensus statement is being issued to clarify and define the criteria for
surgical journal authorship.
The following guidelines should be used to
identify individuals whose work qualifies them as authors as distinct from
those who are contributors to the work under consideration. All persons
designated as authors should qualify for authorship, and all those who
qualify should be so credited.
A. Authorship Criteria
Individuals claiming authorship should meet all of the following 3
conditions:
1) Authors make substantial contributions to conception and design,
and/or acquisition of data, and/or analysis and interpretation of data;
2) Authors participate in drafting the article or revising it critically
for important intellectual content;
3) Authors give final approval of the version to be submitted and any
revised version to be published.
74
Each author should have participated sufficiently in the work
to take public responsibility for appropriate portions of the
content. Allowing one’s name to appear as an author without
having contributed significantly to the study or adding the
name of an individual who has not contributed or who has not
agreed to the work in its current form is considered a breach
of appropriate authorship.
Acquisition of funding, collection of data, contributing cases, or general
supervision of the research group, of itself, or just being the Chair of
the department does not justify authorship if the above criteria are not
fulfilled.
B. Order of Authors
The order of authorship on the byline should be a joint decision of the coauthors. Authors should be prepared to explain the order in which authors
are listed.
C. Multi-Center Studies
When a large, multi-center group has conducted the work, the group should
identify the individuals who accept direct responsibility for the
manuscript. These individuals should fully meet the criteria for authorship
defined above and editors will ask these individuals to complete journalspecific author and conflict of interest disclosure forms. When submitting
a group-author manuscript, the corresponding author should clearly indicate
the preferred citation and should clearly identify all individual authors
as well as the group name.
D. Contributors Listed in Acknowledgments
All contributors who do not meet the criteria for authorship should be
listed in an acknowledgments section. Examples of those who might be
acknowledged include: individuals who allowed their clinical experience
(i.e. cases) to be included, a person who provided purely technical help,
writing assistance, or a department Chair who provided only general
support. Financial and material support should also be acknowledged.
Groups of persons who have contributed materially to the paper but whose
contributions do not justify authorship may be listed under a heading such
as "clinical investigators" or "participating investigators," and their
function or contribution should be described - for example, "served as
scientific advisors," "critically reviewed the study proposal," "collected
data," or "provided and cared for study patients."
Because readers may
infer their endorsement of the data and conclusions, all persons listed as
contributors must give written permission to be acknowledged.
E. In Conclusion
This consensus statement is intended as a basic guide for authors. In the
interest of promoting the highest ethics in surgical publishing and the
surgical sciences, we ask that authors take these criteria into careful
consideration when submitting a manuscript to a peer-reviewed surgical
journal.
7.3. Comprovante de envio para a revista SURGICAL ENDOSCOPY
75

Contribuição da ecoendoscopia com punção no diagnóstico dos

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