Chris Thompson's data presented at DDW (Chicago, May 2011)

1. BRIGHAM AND WOMEN’S HOSPITAL
HARVARD MEDICAL SCHOOL
Endoscopic Repair of Dilated
Gastrojejunal Anastomoses Using a
Novel Endoscopic Suturing Device
Pichamol Jirapinyo, Barham K. Abu Dayyeh, James Slattery,
Michele B. Ryan, Rabindra R. Watson, David B. Lautz,
Christopher C. Thompson

2. Background:
Weight Regain
 Definition of success after bariatric surgery
1. Loss of excess weight ≥ 50%*
2. For morbidly obese group (BMI < 50)  BMI < 35 kg/m2**
For super obese group (BMI ≥ 50)  BMI < 40 kg/m2**
 Weight regain is common in this population
* Reinhold RB. Surg Gynecol Obstet 1982; 155:385-394.
** Biron S, et al. Obes Surg 2004; 14(2):160-4.

3. Background:
Prevalence of Weight Regain
 Occurs after post-operative year 1
 Most RYGB patients regain >30% of lost weight
 Over 25% of RYGB patients regained almost all of their lost
weights
Control
Gastric Bypass
30%
Year 1
* Sjostrom L, et al. NEJM 2004; 351: 2683-93.

4. Background:
Etiologies of Weight Regain
 Nutritional habits
 Psychosocial environment
 Genetics
 Fistula
 Increased gastric pouch volume
 Dilated gastrojejunal
anastomosis (GJ)*
* Abu Dayyeh BK, Lautz DB, Thompson CC. Clin Gastroenterol Hepatol 2011; 9(3):228-33.

5. Background:
Dilated GJ
* Abu Dayyeh BK, Lautz DB, Thompson CC. Clin Gastroenterol Hepatol 2011; 9(3):228-33.

6. Background:
Management of Dilated GJ
 Surgical revision
 Complication rate up to 50%*
 Mortality rate up to 2%*
 Endoscopic techniques
 Less invasive
 Multiple options
 Sclerotherapy
 Tissue plication
 Endoscopic suturing
* Schwartz R, et al. Surgery 1988;104:806–12.

7. Endoscopic Suturing Device
Suture arm
Tissue
anchor
Anchor exchange

8. Endoscopic Suturing Device
 Sutures  Cinch
 Absorbable and non-absorbable  To secure closure without
 2-0 & 3-0 Polyglycolic Acid (PGA) the need to tie surgical knots
 2-0 & 3-0 Polypropylene (PP)

9. Endoscopic Suturing Device:
Cinch System
Tissue of interest
Cylinder
Post
Endoscope
Suture
Tissue anchor

10. Pilot Study
 Aim:
 To demonstrate technical feasibility, safety and
short term efficacy
 Study design:
 Prospective interventional case series
 22 consecutive RYGB patients with weight regain
and a dilated stoma

11. Methods
 Procedure
 Performed under general anesthesia
 CO2 insufflation
 2-0 polypropylene
 Technical success
 Successful suture placement with reduction in stoma
size to < 1 cm
 Follow-up
 Follow-up visits at 3, 6, 12 months
 Follow-up endoscopy at 6, 12 months

12. Patient Characteristics
 22 RYGB patients presented with weight
regain
Age 48+9 years
Gender 16/22 (72.7%) female
Time from RYGB 6+2 years
Stoma diameter 25.5+4.3 mm
Pouch length 5.3+2.0 cm

13. Patient Characteristics
Comorbidities Pre-gastric Post-gastric Time of
bypass bypass suturing
Diabetes 54.5% 22.7% 27.3%
Hypertension 54.5% 27.3% 36.4%
GERD 31.8% 13.6% 13.6%
Hyperlipidemia 27.3% 18.2% 27.3%
Obstructive sleep apnea 13.6% 0% 4.5%

14. Patient Characteristics
Average pre-bypass weight 342.42+75.36 lbs
Average nadir weight 206.23+57.58 lbs
Average weight at suturing 260+68.62 lbs
400
350
Weight (lbs)
300
250 38.75%
200
150
100
Pre-bypass Nadir weight Weight at
weight suturing

15. Technique
 Outlet reduction:
 Tissue ablation (APC)
 Interrupted stitches at 4
2
the anastomosis margin
 Goal reduction to < 1cm
 Pouch reduction:
1
 Interrupted stitches in the 3
pouch to reduce its
volume

16. Technique

17. Results
Outlet (n=11) Pouch (n=11)
Mean procedure time 28.6+21.6 mins 14.8+9.1 mins
Median stitches [range] 3 [1-7] 2 [1-5]

18. Results
> 30 mm
6 mm
Cinch

19. Results
 Technical success: 100% (22/22)
 Post stomal diameter: 5.6 + 1.9 mm (78% reduction)
Intra-procedural complications 9.1% (2/22)
• Small esophageal abrasion from an overtube 1
• Arterial bleeding after stitch placement 1
Post-procedure complications 27.3% (6/22)
• Retching, nausea/vomiting 4
• Stenosis requiring balloon dilation 1
• GI bleeding requiring blood transfusion 1

20. Results
Average weight loss 22.5+13.4 lbs
Average follow-up time 3 months
% weight regain loss 60.39%
% excess weight loss 21.54%
N = 18/20 (90%)
20 out of 22 patients due for a 3 month follow-up

21. Results
400
Weight (lbs)
300 60.39%
200
100
pre- nadir weight at weight at
bypass weight suturing 3 months
weight Average

22. Individual Weight Trends
Weight (lbs)

23. Follow-up Endoscopy
Patient 5:
-3 lbs
Initial 20 mm
procedure
4 mm
3 months

24. Follow-up Endoscopy
Patient 14:
-31 lbs
Initial
procedure
3 months
Tissue anchor

25. Stoma vs. Pouch
10 outlet 8 outlet +
pouch
Average weight loss 15.6 lbs 30.9 lbs
Average follow-up time 94.1 days 86 days
% weight regain loss 63.2% 66.1%
% excess weight loss 16.7% 26.3%
N = 18

26. Limitations
 Small number of patients
 Short term outcomes
 Single tertiary center
 Nutritional and physical activity history not
included

27. Conclusion
 Reducing GJ anastomosis size using this novel
endoscopic suturing device is technically feasible
and appears safe
 This technology could provide an option for
treating weight regain in RYGB patients
 This technology may also have other applications:
 Ulcer oversewing
 Fistula closure