Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT01871896

Collaborator

(none)

Enrollment

Location

Arm

107

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity Weight Loss	Device: Endoscopic Suturing to Create Early Satiety	N/A

Detailed Description

The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is >50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism. The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts.

It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as >2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%.

The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss.

It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision.

Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Apollo OverStitch for Bariatric Surgery Revision After Weight Loss Failure

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Weight Gain Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.	Device: Endoscopic Suturing to Create Early Satiety Evaluating the efficacy of endoscopic suturing for weight loss. Other Names: Endoscopic Cerclage Bariatric Surgery Revision Apollo EndoStitch Apollo OverTube

Arm

Intervention/Treatment

Experimental: Weight Gain

Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.

Device: Endoscopic Suturing to Create Early Satiety

Evaluating the efficacy of endoscopic suturing for weight loss.

Other Names:

Endoscopic Cerclage

Bariatric Surgery Revision

Apollo EndoStitch

Apollo OverTube

Outcome Measures

Primary Outcome Measures

Weight loss [2 years]
We will track patient's weight after their endoscopic bariatric surgery.

Secondary Outcome Measures

Resolution of Co-morbidities [2 years]
We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.
Tolerance [2 years]
We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Previous Roux-En-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
Failure to lose >50% of their excess body weight after 1 year
Failure of weight loss despite maximal medical therapy and medically-supervised diets

Exclusion Criteria:

Esophageal Stricture
Marginal Ulcer at the gastrojejunostomy anastomosis
Non-compliance with bariatric follow-up
Gastric ulcers
Paraesophageal hernias

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Stanley J Rogers, MD, University of California, San Francisco
Principal Investigator: Jonathan T Carter, MD, University of California, San Francisco
Principal Investigator: John P Cello, MD, University of California, San Francisco
Principal Investigator: Matthew Lin, MD, University of California, San Francisco