Endoscopic Management of Bariatric Surgical Complications

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Endoscopic Management of Bariatric Surgical Complications
John A. Martin, MD
Endoscopic Management of
Bariatric Surgical Complications
ACG Annual Postgraduate Course 2013
A Practical Approach to Clinical Gastroenterology and
Hepatology
October 13, 2013
San Diego Convention Center • San Diego, California
John A. Martin, MD
Northwestern University Feinberg School of Medicine
The problem
Obesity Trends* Among U.S. Adults: BFRSS, 2010
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
20%–24%
25%–29%
≥30%
Source: Behavioral Risk Factor Surveillance System, CDC.
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John A. Martin, MD
Obesity Trends* Among U.S. Adults
BRFSS, 1990, 2000, 2010
(*BMI 30, or about 30 lbs. overweight for 5’4” person)
2000
1990
2010
No Data
<10%
10%–14%
15%–19%
20%–24%
25%–29%
≥30%
The problem


Obesity is now more prevalent worldwide than malnutrition from hunger
1.6 billion adults are overweight


≥ 400 million adults are obese
By 2015, 2.3 billion adults will be
overweight

> 700 million adults will be obese.
http://www.cdc.gov/obesity/data/trends.html
World Health Organization, Obesity: preventing and managing the global epidemic: Report of a WHO consultation, WHO Technical
Report Series 894, World Health Organization, Geneva, Switzerland (2000).
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John A. Martin, MD
The solution

Lifestyle modification





Diet
Exercise
Medication
Surgery
Minimally invasive options
Why surgery?
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John A. Martin, MD
Why surgery?

203 women


randomized to
control group vs
home exercise
Results

Some weight
reduction in first 6
months, but no
difference noted at
1 year
Mediano MF, et al. A randomized clinical trial of home-based exercise combined with a slight caloric
restriction on obesity prevention among women. Prev Med. 2010 Sep-Oct;51(3-4):247-52.
Sjostrom, et al. N Engl J Med 2007;357:741. Effects of
Bariatric Surgery on Mortality in Swedish Obese Subjects.
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John A. Martin, MD
Understanding bariatric
surgical anatomy



Restrictive procedures
Malabsorptive procedures
Combination restrictive and
malabsorptive procedures
Restrictive Procedures
Gastric pouch
Mesh or silastic
ring/band
Adjustable
Lap band
Subcutaneous
port
Illustration: John E. Pandolfino, MD
VBG
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Lap Band
5
John A. Martin, MD
Malabsorptive Procedures
BPD
BPD + Duodenal Switch
Illustrations: John E. Pandolfino, MD
Roux-en-Y Gastric Bypass:
restrictive and malabsorptive
Gastric Pouch
Remnant
Stomach
Anastomosis
Jejunojejunostomy
Illustration: John E. Pandolfino, MD
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John A. Martin, MD
Upsides of bariatric surgery

Safe and effective



Rapid weight loss
Improved comorbidities
Durable results
Illustrations:
John Pandolfino, MD
Upsides of bariatric surgery


The only durably
effective therapy for
severe obesity is
currently surgery
Significantly reduces
the risk of mortality
associated with
obesity
M. Magnusson, et al. Five-year results of laparoscopic vertical banded
gastroplasty in the treatment of massive obesity, Obes Surg 12 (2002),
pp. 826–830.
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Illustrations:
John Pandolfino, MD
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John A. Martin, MD
The downsides of bariatric surgery:
gastrointestinal complications

Complications common to all bariatric surgery




Complications occurring more commonly after
gastric banding





Gallstone disease
Peptic ulcer disease (PUD)
Gastroesophageal reflux disease (GERD)
GERD
Food impaction
Band displacement
Band erosion
Complications occurring more commonly in
Roux-en-Y gastric bypass (RYGB), gastric
resection, and biliopancreatic diversion (BPD)


Anastomotic complications
Suture-line and staple-line complications
Clinical case: Initial Presentation








41 year-old female
Hypertension, Diabetes, DJD, OSA
BMI 41 kg/m2
Underwent uncomplicated RYGB 5 months
ago
Did well postoperatively and transitioned to
“regular” diet after 2 months
Taking MVI, Ca2+, B12
Has lost 50 lbs
Developed progressive N, V and abdominal
pain 6 weeks ago
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Clinical case: Initial Presentation






Upper GI X-ray 3 weeks ago showed
“possible 3mm ulcer distal to gastrojejunal
anastomotic line”
Treated with omeprazole 20 mg BID PO with
minimal relief
Always nauseated, afraid to eat because it
leads to pain and vomiting
Currently only eating 2-3 times a day, less
than 3 oz at a time, minimal protein
Tolerating PO liquids
Admitted to hospital with dehydration
Clinical case: diagnostic workup

What would you do first?
Repeat UGI Xray
 EGD
 CT abdomen
 Surgical exploration
 Other

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John A. Martin, MD
Diagnostic Considerations





Obstructive symptoms (pain, N, V) are the
most common presenting symptoms after
RYGB
Abnormalities vary from none (dietary
indiscretion) to more serious (ulcer, stricture
most common)
UGI may miss post-anastomotic disease
(poor filling beyond)-ulcers invariably postanastomotic
In the absence of peritoneal signs, EGD more
likely to be useful than CT (leaks, closedloop obstruction, GOO)
Exploration is almost never necessary
What to recommend now?
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John A. Martin, MD
What to recommend now?






Increase PPI
dose (add
sucralfate?)
Test for H. pylori
TPN
No smoking
No NSAIDs
All of the above
Complications of Roux-en-Y
Gastric Bypass (RYGB)
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John A. Martin, MD
Postoperative Complications
Perioperative mortality of bariatric surgery is less
than 1% but morbidity can be substantial:
Early (within 30 days)






Mortality 1%
Anastomotic Leak 1.5%
Pulmonary Embolism 2%
Acute Gastric Distention
rare
Pneumonia 1.9%
Wound Infection 6%
Late


Stomal Stricture 3 – 20 %
Stomal Ulceration 3 – 20 %






Marginal ulcer (J)
Stomal ulcer (GP)
Staple line disruption 1%
Internal Hernia rare
Incisional Hernia 15%
Fistula rare
Anastomotic Complications:
where do they occur?

Pouch

Anastomosis



Stomal ulcer
Marginal ulcer
Anastomotic stricture

Remnant stomach

Duodenum



PUD
PUD
Roux anastomosis



Bleeding
Stricture
Ulceration
Illustrator: John E. Pandolfino, MD
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John A. Martin, MD
Anastomotic Ulcer



Occur in 3-20% of patients
after RYGB
Usual presentation is
epigastric pain, but nausea
and/or vomiting may
accompany pain or be the
sole presenting symptom(s)
Ulcers on jejunal side
(marginal ulcers) require
careful endoscopic
examination to detect
Anastomotic Ulcer
 Above: Wash well!
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 Below: Look beyond!
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John A. Martin, MD
Anastomotic Ulcer Treatment

Treatment is medical



Acid suppression with PPI will
heal nearly all
Sucralfate
Eradicate H. pylori

Schirmer, et al., 2002: marginal
ulcers with + without preop HP
screening
– +screen 2.4%
– -screen 6.8%
– P<0.05

Rare cases require
reoperation
Case 2: Initial Presentation


37 year-old woman
Morbidly obese since teen years







HTN
DM 2
GERD
Underwent RYGB 7 weeks ago
Lost 35 lbs in 6 weeks
Never tolerated solids well, now not
tolerating liquids either
Epigastric pain & vomiting 2 weeks
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John A. Martin, MD
What is your differential
diagnosis?
Case 2: Diagnostic workup?







UGI Xray
EGD
CT abdomen
Surgical consultation
Ultrasound
Bloodwork
Other
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John A. Martin, MD
Case 2: Endoscopic findings



What is your diagnosis?
What are your treatment
options?
What is the treatment of
choice?
Anastomotic Stricture





Occur in 10% of RYGB patients
Usual presentation is vomiting or
early satiety with or without
nausea, but abdominal pain may
also present
Stoma diameter usually greater
than 1cm when created
Stricture arbitrarily defined as
inability to pass standard
diagnostic gastroscope across
anastomosis without resistance
May be early or late complication
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John A. Martin, MD
Anastomotic Stricture Treatment
Treat Endoscopically
stricture
Gastrograffin swallow
Endoscopic view of
stomal stenosis with
ulceration
Dilation with a
through-the-scope
balloon dilator
From Martin and Pandolfino, Curr Gastroenterol Rep 2005.
Anastomotic Stricture

Endoscopic balloon dilation



Short through-the-scope dilation balloon,
with or without guidewire
Balloon diameter approximating
anastomotic diameter at original operation
More than one session may be required
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Leaks, fistulas, suture-line and
staple-line disruptions


Can occur at suture line or at
anastomosis
Most common fistula postRoux-en-Y gastric bypass is
between gastric pouch and
gastric remnant
Fistula to excluded
stomach
Left: pouch-remnant
gastro-gastric fistula.
Gastric pouch
Right: staple-line
disruption revealing
surgical drain and
suture on serosal
side of gastric pouch
Gastric pouch
Drain
Drain
Gastric pouch
Leaks, fistulas, suture-line and
staple-line disruptions
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2
3
4
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John A. Martin, MD
Leaks, fistulas, suture-line and
staple-line disruptions
1
2
3
4
Leaks and Fistulas
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John A. Martin, MD
Leaks and Fistulas
Leaks and Fistulas
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John A. Martin, MD
Leaks and Fistulas
Leaks and Fistulas
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John A. Martin, MD
Leaks and Fistulas
Leaks and Fistulas
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John A. Martin, MD
Leaks and Fistulas
Leaks and Fistulas
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John A. Martin, MD
Leaks and Fistulas
Leaks and Fistulas
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Leaks and Fistulas
Leaks and Fistulas
Fistula closed
Anastomosis
widely patent
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John A. Martin, MD
Removing Foreign Material
Removing retained staples: why bother?
Ulcers
1
2
3
4
Removing Foreign Material
Removing retained sutures: why bother?
Ulcers
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2
3
4
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John A. Martin, MD
Removing Foreign Material
Removing retained sutures: why bother?
Ulcers
1
2
3
4
Strictures
Removing Foreign Material
Removing retained sutures: more than meets the eye
YES!
1
2
3
4
NO!
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Removing Foreign Material
Removing retained sutures: what to do
1
2
3
4
Removing Foreign Material
Removing retained sutures: double-channel scope
approach
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2
3
4
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John A. Martin, MD
Gastrointestinal Bleeding

Anastomotic bleeding



Peptic ulcer disease

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

Pouch-enteric anastomosis
Jejuno-jejunostomy
anastomosis
Gastric pouch
Gastric remnant
Duodenum
Approach to afferent Roux
limb or jejuno-jejunostomy
anastomosis requires deepenteroscopy,
laparoscopically-assisted
endoscopy, or surgery
Artwork: John E. Pandolfino, MD
Complications of Laparoscopic
Adjustable Gastric Banding
(LAGB)
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John A. Martin, MD
Laparoscopic Adjustable Gastric
Band
Endoscopic Management of PostGastric Banding Complications
 Symptoms similar to RYGB patients:
GERD
symptoms, nausea, vomiting, pain, dysphagia


Endoscopist’s role much more diagnostic,
much less therapeutic
Endoscopically identifiable etiologies
include
 GERD-related stigmata
 Band overinflation
 Peptic ulcer disease
 Band slippage or gastric prolapse
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John A. Martin, MD
Gastric Banding Complications





Food impaction / pouch
outlet obstruction
Band displacement / slippage
Band erosion
Gastric pouch dilatation
Esophageal dilatation
Gastric Banding Complications





Food impaction / pouch
outlet obstruction
Band displacement / slippage
Band erosion
Gastric pouch dilatation
Esophageal dilatation
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John A. Martin, MD
Gastric Banding Complications





Food impaction / pouch
outlet obstruction
Band displacement / slippage
Band erosion
Gastric pouch dilatation
Esophageal dilatation
Gastric Banding Complications





Food impaction / pouch
outlet obstruction
Band displacement / slippage
Band erosion
Gastric pouch dilatation
Esophageal dilatation
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John A. Martin, MD
Gastric Banding Complications





Food impaction / pouch
outlet obstruction
Band displacement / slippage
Band erosion
Gastric pouch dilatation
Esophageal dilatation
Gastric Banding Complications





Food impaction / pouch
outlet obstruction
Band displacement / slippage
Band erosion
Gastric pouch dilatation
Esophageal dilatation
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John A. Martin, MD
Gastric Banding Complications

Band erosion
Video courtesy
Prof. Raul
Monserrat,
Caracas,
Venezuela
Sleeve Gastrectomy Complications
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Sleeve Gastrectomy Complications
Sleeve Gastrectomy Complications
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John A. Martin, MD
Sleeve Gastrectomy Complications
Sleeve Gastrectomy Complications
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John A. Martin, MD
Endoscopic Management of Other
Bariatric Surgical Complications
Endoscopic Management of Other
Post-Bariatric Surgery Complications

Bile duct stone
management
 Post-gastric
banding
 Post-RYGB
Laparoscopicallyassisted ERC
 PTC
 Via deep
enteroscopy
(Roux ≤ 150 cm)

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Schreiner, et al.
Gastrointest
Endosc
2012;75:74856.)
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John A. Martin, MD
Endoscopic Management of Other
Post-Bariatric Surgery Complications




Bile duct stone management
Endoscopic removal of
eroded / lumenalized band
(VBG)
Endoscopic removal of endoluminal
balloons
Perforation → clip and co-manage
with surgical colleague?
Endoscopy Post-Bariatric Surgery
Symptomatic indications for EGD
 Threshold is lower than in non-bariatric patients







Vomiting +/- nausea
Abdominal pain (usually epigastric)
Weight gain / decelerated weight loss
GI bleeding
 Hematemesis
 Melena
Bloating (possibly)
Vague abdominal discomfort (possibly)
Jaundice (possibly)
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John A. Martin, MD
What if endoscopy doesn’t
provide an answer?
Post-endoscopic Workup of PostBariatric Surgery Complications
 Symptoms including GERD nausea, vomiting,
pain, bloating




Consider CT first if pain is main symptom
Consider SBFT or CT enterography if
nausea or bloating are pre-eminent
Consider US if symptoms are pancreaticobiliary in character, especially if GB in
situ; MRCP if LFT’s are elevated as well
Role of capsule endoscopy undetermined
in this population: case-by-case basis for
bleeding or pain; role for Agile patency
capsule?
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John A. Martin, MD
Abdominal pain
Upper abdominal pain
Heartburn alone?
Yes
No
Treat empirically with
acid suppression (PPI)
No
Epigastric
Right upper abdomen
Upper GI endoscopy
to exclude GERD,
PUD, anastomotic
ulcer or stricture
Check liver enzymes,
ultrasound to exclude
biliary source
Endoscopy normal
Abdominal CT scan
Normal
Nausea and vomiting
Nausea or vomiting
Nausea alone?
Yes
No
Consider GERD, PUD,
anastomotic ulcer
Vomiting
EGD to exclude
Treat
EGD
anastomotic stricture, food
endoscopically
abnormal impaction or bezoar, PUD,
or medically
or GERD
EGD normal
Abdominal CT scan and consider
systemic or CNS etiology
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EGD or
empiric
treatment
Check liver enzymes,
ultrasound to exclude
biliary source
Normal
40
John A. Martin, MD
What do I need to get started?
Bariatric endoscopist’s toolbox

Necessities (it doesn’t take a lot to get started)



Diagnostic endoscope
Standard biopsy forceps
Hydrostatic dilation balloons


YES!
Diameter: 8 – 16 mm
Length: 4 – 6 cm (“pyloric” or “colonic”)
NO!
– Non wire-guided (when scope visualizes jejunal lumen) $
– Wire-guided (when scope can’t visualize jejunal lumen) $$
– Guidewire

Endoscopic suture scissors



Reusable
“surgical scissors”, NOT “endoscopic loop cutter”
Small rat-tooth forceps
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John A. Martin, MD
Bariatric endoscopist’s toolbox

Necessities (though you’ll reach for them
infrequently)

Hemostatic clips









Small
Large
Small rat-tooth forceps
Large rat-tooth forceps
Snares
Foreign body retrieval net
Stone extraction basket
Retrieval forcep (tripod, quadripod, etc.)
Overtube
Bariatric endoscopist’s toolbox

Luxuries or occasional-use instrumentation








Dual-channel therapeutic endoscope
Pediatric or transnasal-diameter endoscope
Fluoroscopy
Propofol / MAC anesthesia
Pseudocyst drainage needle-catheter (19 or 21 ga)
APC unit (with multiple probes)
Cytology brush
Deep enteroscope (for Roux-en-Y issues)


Balloon-overtube type
Rotational-type
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John A. Martin, MD
ASGE / SAGES Clinical Practice
Guideline
Anderson, MA, et al. Gastrointest Endosc 2008;68:1.
Access at: www.asge.org
Conclusion




In bariatric patients, scope sooner rather than later
Change is opportunity
 New operations create new anatomy with new
complications
 Minimally invasive surgery interfaces seamlessly
with interventional endoscopy
 Both create opportunities for high-impact
endoscopy
Novel technology & concepts are spawning new
endoscopic techniques to manage bariatric surgical
complications definitively
A comprehensive interdisciplinary treatment plan
constitutes the foundation for every successful
endoscopic treatment of a bariatric complication
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Mihir S. Wagh, MD
ERCP in Patients with Surgically Altered
Upper Gastrointestinal Anatomy
Mihir S. Wagh, MD
Division of Gastroenterology
University of Florida
Gainesville, FL
Agenda
• Post-surgical Anatomy
• Avenues available for access for ERCP
• Tools
• Efficacy
• Summary for approach to a patient with altered
GI anatomy for ERCP
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Mihir S. Wagh, MD
A Brief Overview
Gainesville, Florida
Post Surgical Anatomy
Whipple
Billroth II
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Mihir S. Wagh, MD
Post Surgical Anatomy
Choledocho-jejunostomy
RY Gastric Bypass
The Dilemma
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Mihir S. Wagh, MD
Avenues for ERCP
• Endoscopic
– Duodenoscope
– Pediatric colonoscope
– Overtube-assisted enteroscopy
 Single and double balloon enteroscopy
 Spiral enteroscopy
– EUS-guided antegrade access
• Percutaneous
– Via gastrostomy
• Surgical
– Lap-assisted ERCP
Single and Double Balloon Assisted ERCP
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Mihir S. Wagh, MD
Single and Double Balloon Assisted ERCP
• Success in reaching bilio-pancreatic limb: 6090%
• Successful ERCP: 46-80%
• Using enteroscope; or replacing enteroscope
with duodenoscope through overtube after
reaching papilla or duct-enteric anastomosis
Lopes J Hepatobil Pancr Sci 2011
Balloon Assisted ERCP
Study
Patients
Anatomy
Diagnostic Therapeutic
Success
Success
(%)
(%)
Neumann
13
RY
anastomosis
62
54
Dellon
4
RY
anastomosis
75
50
Itoi
13
B-II or
RY
anastomosis
----
77
Neumann Digestion 2009
Dellon Dig Dis Sci 2009
Itoi Am J Gastro 2010
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Mihir S. Wagh, MD
Spiral Enteroscopy
Prospective Evaluation of Spiral Overtube-Assisted
ERCP in Patients With Surgically Altered Anatomy
Wagh MS GIE 2012
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Mihir S. Wagh, MD
Wagh MS GIE 2012
Prospective Evaluation of Spiral Overtube-Assisted
ERCP in Patients With Surgically Altered Anatomy
Wagh MS GIE 2012
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Mihir S. Wagh, MD
Multicenter US Experience of Single-balloon,
Double-balloon and Rotational Overtubeassisted Enteroscopy ERCP
• Retrospective study at 8 US referral centers
• 129 patients with long-limb surgical bypass
• Enteroscopy success (reaching the target):
92/129 (71%)
• ERCP success (completing intended
pancreatobiliary intervention): 81/129 (63%)
• ERCP success after reaching target: 81/92 (88%)
Shah RJ et al GIE 2013
Multicenter US Experience of Single-balloon,
Double-balloon and Rotational Overtubeassisted Enteroscopy ERCP
• ERCP success rates similar between RY gastric
bypass and non-RY anatomy
• ERCP success rates similar among SBE, DBE
and rotational overtube assisted enteroscopy
• Procedural complications: 12/129 (12%)
Shah RJ et al GIE 2013
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Mihir S. Wagh, MD
Limitations Of The Overtube-Assisted
ERCP Approach
• Addressing the papilla and cannulation of the
duct of intent is difficult with views provided by
the forward-viewing enteroscope
• Lack of elevator
• ERCP accessories are limited and special long
accessories are required due to the long length
(200 cm) of the enteroscope
Via Gastrostomy
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Mihir S. Wagh, MD
ERCP via
Surgical Gastrostomy Tract
• 1998: Baron and Vickers used surgical
gastrostomy as access for ERCP
– RYGB and recurrent pancreatitis
– 24 Fr tube placed and dilated to 38 Fr
after 2 weeks
– Treatment of sphincter of Oddi
dysfunction
Baron GIE 1998
ERCP via
Percutaneous Gastrostomy Tube
• Feeding tube is placed into the excluded
stomach under US or CT guidance
• Requires a delay for the ERCP to allow tract
to mature (not useful for urgent cases)
• Allows access for repeat ERCP
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Mihir S. Wagh, MD
Lap-assisted ERCP
• Duodenoscope is
inserted through a
trocar into the
desired lumen of
the GI tract
(excluded stomach)
• Associated with
risks of anesthesia
and surgery
Lap-assisted ERCP
• Biliary cannulation success in 9/10 (90%)
• Pancreatic cannulation success in 3/3
(100%)
• Overall, technical success 95%
• Tension pneumothorax in 1 patient
responded to chest tube
Lopes GIE 2009
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Mihir S. Wagh, MD
Lap-assisted ERCP
• Retrospective study
• Access to papilla and cannulation
successful in all 15/15 (100%)
• Therapy:
– Biliary sphincterotomy in 14
– Pancreatic sphincterotomy in 2
• No complications related to endoscopic
portion (ileal perforation in 1 required
surgery on day 3)
Saleem et al. J Gastrointest Surg 2012
Lap-assisted ERCP
• Mean duration of the procedure:
45 min (range 10 – 85)
• Mean post-procedure hospital stay:
3.56 days (range 2 – 8)
Saleem et al. J Gastrointest Surg 2012
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Mihir S. Wagh, MD
Laparoscopy-Assisted Versus Balloon EnteroscopyAssisted ERCP in Bariatric Post-Roux-en-Y gastric
Bypass Patients
• Retrospective review of 56 bariatric post-RYGB
patients who underwent ERCP
– 32 patients underwent BEA-ERCP
– 24 underwent LA-ERCP
• LA-ERCP was superior to BEA-ERCP in
– Papilla identification (100% vs 72%, P = 0.005)
– Cannulation rate (100% vs 59%, P < 0.001)
– Therapeutic success (100% vs 59%, P < 0.001)
Schreiner GIE 2012
Laparoscopy-Assisted Versus Balloon EnteroscopyAssisted ERCP in Bariatric Post-Roux-en-Y gastric
Bypass Patients
• Total procedure time was shorter (P < 0.001) and
endoscopist time was longer (P = 0.006) for BEAERCP
• No difference in hospital stay or complication
rates between the 2 groups
• In the BEA-ERCP group, Roux limb +
biliopancreatic limb length (from ligament of
Treitz to jejunojejunal anastomosis) less than
150 cm was associated with therapeutic success
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Mihir S. Wagh, MD
Via Transgastric Stents
“Novel Approach to Therapeutic ERCP After Long-limb
Roux-en-Y Gastric Bypass Surgery Using Transgastric
Self-expandable Metal Stents:
Experimental Outcomes and First Human Case Study”
•
Balloon-assisted enteroscopy
(BAE) allowed access to the
excluded stomach with creation
of a percutaneous endoscopic
gastrostomy (PEG)
•
SEMS was placed through the
PEG tract allowing antegrade
transgastric ERCP during 1
procedure
•
9 animals and 1 human patient
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Baron GIE 2012
57
Mihir S. Wagh, MD
EUS Assisted Approach
• Alternative approach after (failed) enteroscopybased ERCP
• Techniques:
– Hepatico-gastrostomy
– EUS-rendezvous
– EUS-guided antegrade therapies
• Antegrade biliary stenting
• Antegrade biliary balloon dilation
• Antegrade biliary stone management
EUS guided hepatic
duct access
Antegrade biliary
stent
Iwashita Dig Dis Sci 2013
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Mihir S. Wagh, MD
Antegrade biliary stone
management
Antegrade biliary
dilation
Iwashita Dig Dis Sci 2013
Summary
• Billroth II
• Gastro-jejunostomy
• Whipple
Duodenoscope
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• RYGB
• RY choledocho/hepaticojejunostomy
Enteroscope or
Lap-assisted
59
Mihir S. Wagh, MD
Summary
Native papilla
Short Roux Limb
• Consider
duodenoscope
(difficult)
Without native papilla
(i.e. with duct-enteric
anastomosis)
Long Roux Limb
• Lap-ERCP
• Gastrostomy tract
Short Roux Limb
• Colonoscope
• Enteroscope
Long Roux Limb
• SBE/DBE
• Spiral Enteroscopy
Take-Home Message
• Review details of surgically altered anatomy
• Assess indication
• Obtain surgical consultation and evaluate
surgical risk
• Utilize locally available expertise
– Interventional Endoscopy
– Interventional Radiology
– Surgery
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Mihir S. Wagh, MD
Homework
Thank You
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Gregory G. Ginsberg, MD, FACG
Endoscopic Therapies for Obesity:
where we are and where we go?
Gregory G. Ginsberg, M.D.
Professor of Medicine
University of Pennsylvania Perelman
School of Medicine
Gastroenterology Division
Director of Endoscopic Service
PENN Medicine
Abramson Cancer Center
DISCLOSURE
Relevant Financial Relationship(s)
None
Off Label Usage
None
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Gregory G. Ginsberg, MD, FACG
Obesity

Obesity is a metabolic
disease



Defined as BMI ≥ 30
A modern problem


Severe toll of co-morbid
illness
Statistics for it did not even
exist 50 years ago
Increase of




Convenience foods
Labor-saving devices
Motorized transport
More sedentary lifestyles
Obesity: Global Problem
• High-, mid- and low-income countries; more prevalent than hunger
• By 2015, ~2.3 billion adults overweight & > 700 million obese
• In 2005, 20 million children < 5 yr old overweight globally
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Gregory G. Ginsberg, MD, FACG
Obesity in the United States
Rural and urban
Centers for Disease Control and Prevention
Body Mass Index Vs. Mortality
Exponential Increase in Risk
400
Relative Mortality Rate
350
High risk
Medium risk
Low risk
300
250
200
150
100
50
0
16
19
22
25
28
31
34
BMI (kg/m2)
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40
45
Courtesy, David Metz, MD
64
Gregory G. Ginsberg, MD, FACG
Obesity-Related Co-Morbidities






All-cause mortality
Heart disease
Hypertension
Stroke
Dyslipidemia
Cholelithiasis






Type II diabetes
Osteoarthritis
Sleep apnea
Malignancies
Reduced QOL
Social
marginalization
Not only the human toll, but their associated costs
for diagnosis, management, and disability
Biology Is Against Us

“The essence of all living things is to
obtain energy and reproduce”


We evolved to crave sweet, salty, and
fatty foods


Dean Robert Chase, Biol. Lafayette Col
Gary Beauchamp, Phila Inquirer, 4/24/2011
Biology does not have to be our
destiny
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Gregory G. Ginsberg, MD, FACG
Diets and Medications Have
Limited Efficacy

Lifestyle: TWL 4kg



Medications achieve better weight
loss than diet/exercise alone (3-5 kg)




diet, counseling and exercise
3-5% of maintain weight loss for 5 years
High rates of attrition (30-40%)
Cost of medications (lifelong?)
Adverse events
Cost of ineffective therapy
Mann T. et al. American Psychologist 2007;62(3):220-233
Padwal RS, et al. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD004094
Bariatric Surgical Approaches
Lower Morbidity / Lower Risk
Less Effective
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Higher Morbidity / Higher Risk
More Effective
66
Gregory G. Ginsberg, MD, FACG
Obesity
NIH Consensus Conference ,1985
NIH Clinical Guidelines pub# 98-4083, Sept 1998
Class
Underweight
Normal
Overweight
Obesity I
Obesity II
Obesity III
Courtesy, Christopher Thompson, MD
BMIKg/m2
18
18-24.9
25-29.9
30-34.9
35-39.9
>40
Qualify for surgery
BMI ≥ 35 with co-morbid illness
BMI ≥ 40
Bariatric Surgical Outcomes
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Gregory G. Ginsberg, MD, FACG
Limitations of Bariatric
Surgery

20 million Americans are heavy
enough to qualify for bariatric
surgery (Andrew Pollack, NYTimes, 3/16/2011)





Only 200,000 have operations each year
Morbidity 3-20%; Mortality 0.1-0.5%
Many patients unfit or unwilling to
undergo surgery
Current cost $12,000 to $30,000
What about the other 99%?
The Case for Endoluminal
Bariatric Procedure(s)




Obesity problem is increasing
Considerable obesity related
morbidity, mortality, and costs
Lifestyle and medication therapies
under-perform
Operative interventions are effective
but with limited in applicability and
associated with considerable risk
and cost
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Gregory G. Ginsberg, MD, FACG
Endoscopic Bariatric Therapy in the USA

The following is a list of EBT currently
approved for use in the USA:




Endoscopic Bariatric
Therapies

Why should you care?


Obesity is an epidemic with real negative
societal impact
Opportunity to





address an unmet need
achieve a good on behalf of society
expand the endoscopic armamentarium
Millions of healthcare and related $$ at
stake
We have a responsibility to do so
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Gregory G. Ginsberg, MD, FACG
Endoluminal Bariatric Therapies
Task Force
The ASGE is dedicated to advancing patient care and digestive health
by promoting excellence in gastrointestinal endoscopy.
The ASMBS is dedicated to improving public health and well-being
by lessening the burden of the disease of obesity and related diseases.

ASGE




Gregory G. Ginsberg
Steven A. Edmundowicz
Christopher C. Thompson
Gregory A. Cote’

ASMBS




Bipan Chand
Ninh T. Nguyen
Aurora Pryor
Ramsey M. Dallal
ASGE/ASMBS EBT Task Force
Mission:
GIE 2011;74:943-953

Establish thresholds for



Safety
Efficacy
Guide




Development
Investigation
Training
Adoption
“A pathway to endoscopic bariatric therapies”
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Gregory G. Ginsberg, MD, FACG
Endoluminal Bariatric
Procedure Concepts

Restrictive


Malabsorptive




Bypass or barrier to intestinal contact
Neurohumeral


Space occupying or volume reducing
Satiation and other effects
Combinations of the above
Other…
NOTES
Devices to Treat Obesity
http://mediligence.com/blog/2011/01/24/options-in-the-clinical-treatment-of-obesity/

Restrictive Devices



Artificial Fullness Devices










TransPyloric Shuttle BAROnova Therapeutics
BaroSense’s TERIS (Trans-oral Endoscopic Restrictive Implant System)
Endoscopic Intragastric Injection of Botulinum Toxin
EndoVx EUS guided HIFU vagotomy (TEVx)
Appetite Suppressive Devices




GI Dynamics’ EndoBarrier
Gastrx Sleeve-like Device
ValenTx Sleeve
Aspire aspiration therapy
Devices to Control Gastric Emptying


Reshape Duo intragastric balloons
Polymer pills
Full Sense Device
Malabsorption Devices


Transoral Gastroplasty (TOGA)
RESTORe Suturing System™
MetaCure’s Tantalus System
EnteroMedics’ Maestro System for VBLOC
Silhouette Medical’s nObese RF Ablation Device
Gastric Electrical Stimulation

Abiliti Intrapace
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Gregory G. Ginsberg, MD, FACG
Dental Implants

Intra-oral weight loss device

Removable, custommade, oral device
that slows food intake
New Obesity Procedure
Categories

Bridge

Key Features:


Early Intervention


Primary Therapy


Metabolic

Rapid effect
Moderate to high
weight loss
Short term
durability
No permanent
anatomic alteration
Modified from Christopher Thompson, MD
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Gregory G. Ginsberg, MD, FACG
Bridge: To Decrease Surgical Risk






Morbid obesity with its co-morbid illness (OSA, DM,
CAD) is a known risk factor for surgical
complications
 DVT, PE, atelectasis, renal failure, wound
infection, prosthesis failure
Cardiac
Orthopedic
Cancer
Transplant
Bariatric
Intragastric Balloon Therapy





Short-term weight loss of 14-18 kg in
6 months
Relatively safe
Weight loss does not last
Patients regain weight
20% to 40% of patients fail to achieve
any meaningful weight loss
ASGE SER Endoluminal bariatric techniques. GIE 2012;76:1-7
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Gregory G. Ginsberg, MD, FACG
Metabolic therapy…
New Obesity Procedure
Categories

Bridge

Key Features:


Early Intervention


Primary Therapy

Metabolic


Modest weight loss
and/or
Prevention of
weight gain
High safety profile
Durable and/or
repeatable
Modified from Christopher Thompson, MD
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Gregory G. Ginsberg, MD, FACG
Courtesy, Rich Rothstein, MD
New Obesity Procedure
Categories

Bridge

Key Features:


Early Intervention

Primary Therapy

Metabolic

Weight loss profile
to approach that of
bariatric surgery
Safety profile to
exceed that of
bariatric surgery
Modified from Christopher Thompson, MD
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Gregory G. Ginsberg, MD, FACG
Gastrointest Endosc 2011;74:1248-58
TOGa: A Cautionary Tail

Prospective, multicenter, single arm
trial, 53 patients
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Gregory G. Ginsberg, MD, FACG
TOGa Pivotal Trial: Weight Loss
Based on disappointing results, FDA application was
withdrawn and the company was disbanded




Mean %EWL of 25%
“Roll in” subjects (N=18) did better than the rest
While statistically significant, less than 50% achieved
threshold response
Courtesy Sriram Machineni MD
Cross-over patients with only 8%EWL
New Obesity Procedure
Categories

Bridge

Early Intervention

Primary Therapy

Metabolic

Metabolic


Minimal or modest
weight loss
Emphasis on
measurable reduction
in comorbid
conditions
Patients who lose 5% of their total body
weight have significant reductions in diabetes
and cardiovascular risk factors.
Modified from Christopher Thompson, MD
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Gregory G. Ginsberg, MD, FACG
EndoBarrier (GI Dynamics)
Anchoring
mechanism
secures device in
place in
duodenum but
permits removal
Soft, flexible
barrier sleeve
positioned below
pylorus diverts
until the jejunum
Delays metabolic
and endocrine
processes
Duodenojejunal Bypass Sleeve



60-cm long impermeable plastic
sleeve anchored to duodenal bulb
Placed and removed endoscopically
Short term (3 month) comparative
trials +/- sham



m %EWL 19% v 7% (p<.002)
m 8.2 kg v 2.1 kg (p<0.5)
Poor patient tolerance
ASGE SER Endoluminal bariatric techniques. GIE 2012;76:1-7
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Gregory G. Ginsberg, MD, FACG
EndoBarrier™ Improves HbA1c
Week 12
N=9
N=4
Week 30
N=8
N=3
*Week 30 p=0.004
Surg Endosc 2009; 23:650, Ann Surg 2010; 251:236
AspireAssist® Aspiration
Therapy System




Aspiration therapy
20 min after meal
Water lavage
30% of caloric intake
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Gregory G. Ginsberg, MD, FACG
AspireAssist® Aspiration
Therapy System
Mean % Excess Weight Loss as a Function of Time
Threshold Analysis %EWL
Percent weight loss in “Proof-of-Principle” subject
%EWL over Time AT vs. Control Groups
US Pivotal Trial




Trial: 175 patient trial, 11-center trial
Patients randomized 2:1 AT to Control (Lifestyle Therapy)
BMI: 35-55 kg/m2
Centers/ Investigators











Washington University: Steve Edmundowicz, Shelby Sullivan
Boston University: Carolyn Apovian, Chris Huang
Brigham & Women’s: Chris Thompson
Cornell: Louis Aronne , Mike Kahaleh
St. Mary’s: Alan Schorr , J. Matthew Bohning
Penn: Marion Vetter, David Jaffe, Gregory Ginsberg
Howard: Terry Fullum
Northwestern: Bob Kushner, John Martin
Mayo Clinic: Mike Jensen, Barham K Abu
St. Lukes (San Francisco): Nancy Bohanon
VA Center/ UC San Diego: Karen Herbst, Joe Glazer, Sam Ho
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Gregory G. Ginsberg, MD, FACG
The Battle Against Obesity



Medical therapies
Bariatric surgery
Culture change





Education
Access to healthy foods
Realignment of government subsidies
Societal initiatives
Endoscopic Bariatric therapies

Future studies should objectively measure
metabolic outcomes in addition to weight loss
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