Presentation - Quality in Endoscopy

Transcription

Colorectal stenting
Alessandro Repici, MD
Digestive Endoscopy Unit
IRCCS Istituto Clinico Humanitas
Milano, Italy
Quality in Endoscopy: Colonoscopy, Berlin 2012
Metal Stents for Obstructing
Colorectal Cancer
 Dohomoto was credited as the first to report on
metallic stenting in the rectum. Dig End 1991
 Spinelli P et al. Self-expanding mesh stents for
endoscopic palliation of rectal obstructing tumors.
Surgical Endoscopy 1992; 6:72-76
 Spinelli P et al. Rectal metal stents for palliation of
colorectal malignant stenosis. Bildgebung 1993
2007
Br J Surgery 2007
Endoscopic Stent Placement as a Bridge to Surgery in
Malignant Colorectal Obstruction: A Balance between
Study Validity and Real-World Applicability
Barham K. Abu Dayyeh, MD, MPH1 and Todd H. Baron, MD ,Am J Gastroenterology Dec 2011
The premise of self-expandable metal stent placement to restore luminal
continuity in patients with acute left-sided malignant colonic obstruction
is intuitively logical. However, the available body of literature addressing
their benefit in this setting is contradictory
More than two decades later and after multiple retrospective studies and
four randomized, prospective, non-blinded trials, the jury is still out
about their “ real-world ” effectiveness in this setting
The reasons for this are multi-factorial and include shortcomings of the
published literature, variability in case-mix and potential for selection
bias, vast heterogeneity in the technical success rates and risk profiles
of colonic stent placement
Authors’ Conslusions
Implications for practice:
1. Colorectal stenting has no advantages to Emergency surgery in
malignant colorectal obstructions. Emergency surgery appears to have
high clinical success rate compared to colorectal stenting. The stent
related complications are acceptable. Colorectal stenting has the
advantage of shorter hospital stay and procedure time and less blood
loss with comparable mortality and morbidity to emergency surgery.
2. Malignant colonic obstruction is a critical condition and relief by
colorectal stents requires dedicated specialised units with
endoscopic/radiological facilities
3. Colorectal stent insertion should only be performed by experienced
endoscopists or radiologists with adequate interventional experience
Surgical management of malignant LBO
• Patients with malignant LBO are older with more
comorbities and have more advanced diseases
• Mortality rate
5-14%
• Morbidity rate 15-55%
• One-stage surgery in less than 25% of cases
• Temporary ileostomies will be not closed in ¼ of the patients
• Permanent stoma do report a significant lower
health-related quality of life
S. Breitenstein, et al; Systematic evaluation of surgical strategies for acute malignant left-sided colonic
obstruction; British Journal of Surgery 2007; 94: 1451–1460
Large Bowel Obstruction (LBO)
Stage IV
Stage IV
452 patients of mean age 67.5 years were included, of whom 78.8% had an
emergency operation. The most common diagnosis was cancer (58.6%)
After 44 months, only 159 (35.2%) patients had undergone reversal
The most frequent reason why reversal was not done was death (74 [25%]
patients).
The mortality was 3.5%. Complications occurred in 45.2%, with a 6.2% rate of
anastomotic leakage.
Roig JV, Colorectal Disease 2011
Hartmann‘s operation
Of all colon cancer, patients with emergency resection, 33% died in the first year
377 patients were included in the analysis of outcome: 173 (45.9%) had
obstructing cancers at or proximal to the splenic flexure, and 204 (54.1%)
had lesions distal to the splenic flexure.
Overall morbidity rate was 54% in the distal and 55,5% in the proximal colon
The prevalence of anastomotic leakage was significantly higher for rightsided tumours (16.5%) than for left-sided tumours (7.7%) (p = 0.014).
The mean hospital stay was 20.4 days (range, 7–191 days) in the proximal
group and 19.3 days (range, 5–90 days) in the distal group (p = 0.538).
The 30-day mortality rate was 14.5% in the proximal cancer group and
14.7% in the distal cancer group (p = 0.944).
Colorectal Disease 2011
The issue of perforation became dramatic after 2008
Arch Surg 2009
Two more landmark studies
• van Hoof J, et al Lancet Oncology 2011
– Prospective randomized study (25 centers in Netherland)
– 48 received stents and 51 underwent surgery
– Higher 30-day morbidity rate (0·19 (95% CI –0·06 to 0·41) in the
stent group
– 6 patients (13%) reporting early or delayed perforation
– The study prematurely closed after interim analysis
• Pirlet I, et al Surg Endosc 2011
–
–
–
–
Prospective randomized study (9 centers in France)
60 patients, 30 randomized to stenting
56% of technical failure
10% perforation
Bevacizumab-based therapies and
Colonic perforation after SEMS placement
Is it time for a warning?
Bevacizumab-based therapies
Treated
Untreated
P
15.4%
6.8%
0.06
Small AJ et al. GIE 2010
PERFORATION IN COLORECTAL STENTING: A PRELIMINARY ANALYSIS OF LITERATURE DATA
AND A SEARCH FOR RISK FACTORS
E. van Halsema1, J. van Hooft1, P. Fockens1, A. Repici2
1
Department of Gastroenterology & Hepatology, Academic Medical Centre, Amsterdam, The Netherlands
2 Digestive Endoscopy, Istituto Clinico Humanitas, Rozzano (Milan), Italy
UEGW, 2011
Methods
This study was designed as
a literature review with an
additional request for data to
authors of included articles
when
literature
was
insufficient.
Database
MEDLINE was searched
from January 2005 to March
2011 for relevant English
articles
on
colorectal
stenting. Eighty-six studies
met our inclusion criteria; 42
retrospective,
24
prospective, 7 case reports,
5 RCTs, 2 pro- and
retrospective and 6 without
describing study design. A
pooled, univariate analysis
was performed.
Perforation rate per stent type
Baseline Characteristics
Patients
4090 (100.0)
Receiving stent
3865 (94.5)
inability to pass stricture
stent uncertain
perforations
Stenosis
malignant
50 (1.2)
207 (5.1)
3865 (100.0)
3753 (97.1)
benign
98 (2.5)
missing
14 (0.4)
Concomitant treatments
none
chemotherapy
bevacizumab
missing
Stricture dilation
none
1437 (35.1)
637 (15.6)
86 (2.1)
1930 (47.2)
332† (8.1)
intraprocedural post-stent 190 (4.6)
missing
%
Comvi Stent
Dual Stent
Enteral Wallstent
Hanarostent
4
3
2
1
Niti-S Covered
Niti-S D-type
Ultraflex Precision
Wallflex Colonic
0
Stent design
BENIGN STRICTURES 10.2%
p = 0.021; OR 2.17 (95% C.I. 1.05-4.10)
BEVACIZUMAB 12.6%
p = .020; OR 2.17 (95% C.I. 1.06-4.12)
2515 (61.5)
intraprocedural pre-stent 146 (3.6)
reintervention dilation
Conclusions
175 (4.3)
9
8
7
6
5
22 (0.5)
1243 (30.4)
REINTERVENTION DILATION 18.2%
p = .018; OR 3.48 (95% C.I. 1.00-9.83)
Perforation rate
5,1%
Benign strictures, concomitant bevacizumab and reintervention dilation were associated
with increased risk of perforation in colonic stenting. Perforation rates of eight different
stent types varied from 1.6 to 8.1%, but heterogeneity makes it difficult to draw firm
conclusions from this finding.
Self-expandable metal stents for malignant colorectal
obstruction: short-term safety and efficacy 447 patients
(Wallflex Registry)
• Two global registries with 39 academic and community centers
• This study involved 447 patients with malignant colonic obstruction who
received stents (255 PAL, 182 BTS)
• The procedural success rate was 94.8% (439/463), and the clinical
success rates were 90.5% (313/346)
• 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7
(1.8%) cases of pain, and 2 (0.5%) cases of bleeding
Mesiner S, et al GIE 2011
Hapani S, et al Lancet
Oncology 2009
Tan CJ, et al Br J Surg, April 2012
Tan CJ, et al Br J Surg, April 2012
Endoscopic Stent Placement as a Bridge to Surgery in
Malignant Colorectal Obstruction: A Balance between
Study Validity and Real-World Applicability
Barham K. Abu Dayyeh, MD, MPH1 and Todd H. Baron, MD1
Am J Gastroenterol Dec 2011
The individual clinician and the endoscopist
should honestly assess whether the capabilities
for high insertion and low complication rates are
achievable for a particular patient, especially in
those patients at highest risk not only of
complications from emergency surgery but that
of medical management with delayed surgery.
Are we ready to provide this service 24h/7day?
An Italian survey
250
200
Number of Units
150
ERCP
Enteral Stents
100
24H service for bowel
obstruction
10,8%
50
0
Question 1
Question 2
Question 3
Repici A, et al, submitted to UEGW
Stent Colonic
Manufacturer
Expanded length (mm)
Diameter (mm)
TTS/ OTW
Introduction
System Fr size
Working
length (cm)
Evolution Colonic Stent
Cook Medical
60, 80, 100
30/25
TTS
10
230
Boston Scientific/Microvasive,
Natick, MA
57, 87, 117
30/25
OTW
Wallstent®
Colonic & Duodenal
Natick, MA
60, 90
18, 20 ,22
TTS
WallFlex Enteral Colonic Stent
Natick, MA
60,90,120
30/25
27/22
TTS
Colonic Z-Stent®
Cook Medical
Winston-Salem, NC
40, 60, 80, 100, 120
35/25
Silky Colo-Rectal Stent
Stentech Seoul Korea
Ultraflex Precision Colonic
Stent
16
10
135
10
135
230
OTW
31
40
30
TTS
10
70
80
16
18
70
150
20
22
70
150
10
12
140
230
TTS / OTW
10
12
140
230
22
TTS
10.5
210
30/36
OTW
24
70
110
20,25,30
OTW
13
95
30/36
25/30
TTS
10 /24
110 /230
Covered / Uncovered
50,60,70;80,90,100,120,140,160
Niti-S Colorectal Stent
Taewoong-Medical Co., Ltd,
Seoul, South Korea
Uncovered 60, 80, 100
28/20
30/22
30/24
28/20
OTW
Niti-S Colorectal Stent
Taewoong-Medical Co., Ltd,
Seoul, South Korea
Covered
30/22
30/24
OTW
BONA –Stent
Colo-rectal
Standard Sci.Tech Inc
22/24/26
TTS / OTW
BONA –Stent
Colo-rectal
Standard Sci.Tech Inc
Hanaro Colorectal
Stent
M.I TECH Co ltd
ECO stent
Leufen Medizintechnik OHG
SX-ELLA
Stent colorectal
ELLA-CS, Prague, Czech Republic
Micro-Tech colon and rectum
stent
Micro-tech Europe
Dusseldorf Germany
60,80, 100
Uncovered 60, 80, 100
Covered
60,80,100
30/50/80
40,70;100
Uncovered 80,100
82,90,113,135
75,88,112,123,136
Uncovered 80/100/120
Covered
80/100/120
50/70/90
Adapted from Repici A, GIE Clin N Am 2011
105
22/24/26

Presentation - Quality in Endoscopy

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