Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

NCT ID: NCT01871896

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-06-30

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.

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.

Conditions

Morbid Obesity; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weight Gain

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

Group Type: EXPERIMENTAL

Endoscopic Suturing to Create Early Satiety

Intervention Type: DEVICE

Evaluating the efficacy of endoscopic suturing for weight loss.

Interventions

Endoscopic Suturing to Create Early Satiety

Evaluating the efficacy of endoscopic suturing for weight loss.

Intervention Type: DEVICE

Other Intervention Names

Endoscopic Cerclage; Bariatric Surgery Revision; Apollo EndoStitch; Apollo OverTube

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley J Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jonathan T Carter, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

John P Cello, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Matthew Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.

Reference Type: BACKGROUND

PMID: 23567348 (View on PubMed)

Deylgat B, D'Hondt M, Pottel H, Vansteenkiste F, Van Rooy F, Devriendt D. Indications, safety, and feasibility of conversion of failed bariatric surgery to Roux-en-Y gastric bypass: a retrospective comparative study with primary laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2012 Jul;26(7):1997-2002. doi: 10.1007/s00464-011-2140-0. Epub 2012 Jan 19.

Reference Type: BACKGROUND

PMID: 22258299 (View on PubMed)

Kellogg TA. Revisional bariatric surgery. Surg Clin North Am. 2011 Dec;91(6):1353-71, x. doi: 10.1016/j.suc.2011.08.004.

Reference Type: BACKGROUND

PMID: 22054158 (View on PubMed)

deWolfe MA, Bower CE. Using the StomaphyX(TM) endoplicator to treat a gastric bypass complication. JSLS. 2011 Jan-Mar;15(1):109-13. doi: 10.4293/108680811X13022985131570.

Reference Type: BACKGROUND

PMID: 21902955 (View on PubMed)

Thompson CC, Jacobsen GR, Schroder GL, Horgan S. Stoma size critical to 12-month outcomes in endoscopic suturing for gastric bypass repair. Surg Obes Relat Dis. 2012 May-Jun;8(3):282-7. doi: 10.1016/j.soard.2011.03.014. Epub 2011 Apr 19.

Reference Type: BACKGROUND

PMID: 21640665 (View on PubMed)

Raman SR, Holover S, Garber S. Endolumenal revision obesity surgery results in weight loss and closure of gastric-gastric fistula. Surg Obes Relat Dis. 2011 May-Jun;7(3):304-8. doi: 10.1016/j.soard.2011.01.045. Epub 2011 Feb 22.

Reference Type: BACKGROUND

PMID: 21474389 (View on PubMed)

Heneghan HM, Yimcharoen P, Brethauer SA, Kroh M, Chand B. Influence of pouch and stoma size on weight loss after gastric bypass. Surg Obes Relat Dis. 2012 Jul-Aug;8(4):408-15. doi: 10.1016/j.soard.2011.09.010. Epub 2011 Sep 23.

Reference Type: BACKGROUND

PMID: 22055390 (View on PubMed)

Yimcharoen P, Heneghan HM, Singh M, Brethauer S, Schauer P, Rogula T, Kroh M, Chand B. Endoscopic findings and outcomes of revisional procedures for patients with weight recidivism after gastric bypass. Surg Endosc. 2011 Oct;25(10):3345-52. doi: 10.1007/s00464-011-1723-0. Epub 2011 Apr 30.

Reference Type: BACKGROUND

PMID: 21533520 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EndoSurgery

Identifier Type: -

Identifier Source: org_study_id