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