Download - Stomal reduction with Apollo Overstitch
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
BRIGHAM AND WOMEN’S HOSPITAL
HARVARD MEDICAL SCHOOL
Background:Weight Regain
Definition of success after bariatric surgery1. 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
** Biron S, et al. Obes Surg 2004; 14(2):160-4.* Reinhold RB. Surg Gynecol Obstet 1982; 155:385-394.
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
* Sjostrom L, et al. NEJM 2004; 351: 2683-93.
Control
Gastric Bypass
Year 1
30%
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.
Background:Dilated GJ
* Abu Dayyeh BK, Lautz DB, Thompson CC. Clin Gastroenterol Hepatol 2011; 9(3):228-33.
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.
Endoscopic Suturing Device
Suture arm
Anchor exchange
Tissue
anchor
Endoscopic Suturing Device
Sutures
To secure closure without the need to tie surgical knots
Absorbable and non-absorbable 2-0 & 3-0 Polyglycolic Acid (PGA)
2-0 & 3-0 Polypropylene (PP)
Cinch
Endoscopic Suturing Device:Cinch System
Tissue of interest
CylinderPost
Tissue anchor
Endoscope
Suture
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
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
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
Patient Characteristics
Comorbidities Pre-gastric bypass
Post-gastric bypass
Time of 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%
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
100150200250300350400
Pre-bypass
weight
Nadir weight Weight at
suturing
38.75%
Weig
ht
(lbs)
Technique
Outlet reduction:
Tissue ablation (APC)
Interrupted stitches at the anastomosis margin
Goal reduction to < 1cm
Pouch reduction:
Interrupted stitches in the pouch to reduce its volume
1
2
3
4
Technique
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]
Results
> 30 mm
Cinch
6 mm
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
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
Results
100
200
300
400
pre-
bypass
weight
nadir
weight
weight at
suturing
weight at
3 months
60.39%
Weig
ht (lbs)
Average
Individual Weight Trends
Weight (lbs)
Follow-up Endoscopy
3 months
Initial
procedure20 mm
4 mm
Patient 5:
-3 lbs
Follow-up Endoscopy
3 months
Initial
procedure
Tissue anchor
Patient 14:
-31 lbs
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
Limitations
Small number of patients
Short term outcomes
Single tertiary center
Nutritional and physical activity history not included
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