Comparing Reduction With ESD- Versus APC-TORe

Not Applicable

Recruiting

• Conditions: Obesity; Roux-en-y Anastomosis Site; Weight Gain

• Registration Number: NCT06131281
• Lead Sponsor: Carlos Roberto Simons-Linares

Brief Summary

The goal of this clinical trial is to compare two variations of the same procedure used to assist with weight loss in patients who have a history of Roux-en-Y gastric bypass who have experienced weight regain. The procedure being studied is called the Transoral Outlet Reduction (TORe), and the trial will compare two different ways to complete the TORe procedure. The main question\[s\] it aims to answer are:

* Which variation of the TORe procedure results in more weight loss?

* Which variation of the TORe is safer? Participants who are eligible and willing to undergo the TORe procedure to assist with weight loss will have the procedure completed either one of the two ways. All other care will be exactly the same between the two groups. Researchers will compare outcomes between the two procedure variations, looking at which one results in more weight loss, is more successful, and safer.

Detailed Description

Weight regain after having a Roux-en-Y gastric bypass is common. One of the primary reasons for weight regain after bypass is stretching out or "dilation" of the surgical connection created between what is left of the stomach and the small intestine (called the anastamosis). As the ability to suture with the help of a scope inserted through the mouth into the stomach instead of surgery, the transoral outlet reduction (TORe) was developed. The TORe involves suturing around the stretched out anastamosis, allowing it to be pulled tighter and shrink down, resulting in weight loss, and is an entirely endoscopic and reversible procedure. As the procedure advanced, "burning" of the stomach lining using a technique called argon plasma coagulation (APC), in addition to suturing, became the standard way to perform the TORe procedure. The APC helps the stomach tissue shrink even more and heal into place better, causing even more weight loss. This is now the classic way to perform the TORe (hereby called the "c-TORe"), and is now widely used to help patients who have regained weight after gastric bypass.

Multiple studies report the c-TORe results in an average of 8-9% total body weight loss. However more recently, another variation of the TORe was developed, which uses endoscopic submucosal dissection (ESD). In the ESD-TORe (hereby called the E-TORe), the physician makes a small cut in the surface layer of the anastamosis in addition to APC and suturing. In the only study comparing c-TORe to E-TORe, E-TORe resulted in significantly more weight loss. However, there are several limitations to this study that require more investigation.

This clinical trial will compare the c-TORe and the E-TORe. Patients who are eligible and willing to undergo a TORe procedure will be assigned to get either the c-TORe or the E-TORe. They will undergo the procedure with a physician experienced in both types of the procedure. Participants will be followed for one year after the procedure to compare which procedure type results in more weight loss.

Study Timeline

• Study Start: 2023-10-02
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patients with history of Roux-en-Y gastric bypass and weight regain
• Dilated gastrojejunal anastamosis as diagnosed on endoscopy
• Patients undergoing standard of care for treatment of obesity with endoscopic revisional procedure (a.k.a. TORe) who are enrolled in the GI Bariatric Endoscopy program and clinic at the study site

Exclusion Criteria

• Prior revision of gastric bypass
• Active and uncontrolled gastro-esophageal reflux disease defined as ≥ grade C esophagitis
• Active untreated Helicobacter pylori infection
• Malignancy newly diagnosed by endoscopy
• Upper gastro-intestinal conditions such as ulcers, polyps, gastric varices, strictures, congenital or acquired intestinal telangiectasia or other abnormalities that preclude completion of TORe
• Presence of gastrogastric or gastroenteric fistula
• Inability to undergo general anesthesia
• Participating in another ongoing clinical trial of an investigational weight loss drug or device
• Active pregnancy
• Use of anticoagulation therapy or P2Y12 inhibitors which cannot be discontinued for the time frame surrounding the procedure
• Insulin-dependent diabetes mellitus
• Unwillingness to comply with standard post-TORe dietary guidelines and follow-up care
• Any other anatomical, technical or otherwise factor that limits the ability of the endoscopist to perform either E-TORe or c-TORe
• Any additional factor, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the trial protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight change at 6 months	6 months from procedure date	Percent total body weight change 6 months following TORe procedure
Weight change at 12 months	12 months from procedure date	Percent total body weight change 12 months following TORe procedure

Secondary Outcome Measures

Name	Time	Method
Procedure time	Day of procedure	Mean time to complete each procedure type
Technical success	Day of procedure	Rates of technical success of the procedure as determined by the experienced endoscopist performing the TORe procedure
Adverse event rate	One year from date of procedure	Rate of adverse events related to each procedure type
5% total body weight loss	One year from date of procedure	Proportion of subjects who achieved at least 5% total body weight loss

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States