Comparing Reduction With ESD- Versus APC-TORe

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Outcomes of Classic Transoral Outlet Reduction (TORe) Versus Endoscopic Submucosal Dissection-TORe: A Randomized Controlled Trial

Conditions
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Obesity, Roux-en-y Anastomosis Site, Weight Gain

Intervention / Treatment
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* Procedure: E-TORe
* Procedure: c-TORe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-blinded, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-TORe<br>Participants in this arm received the E-TORe procedure | Procedure: E-TORe<br>* The E-TORe utilizes ESD in addition to APC prior to endoscopic suturing. In this approach, a standardized solution of normal saline or hetastarch mixed with methylene blue and epinephrine is injected into the gastric rim of the GJA outlet. The mucosa is then carefully incised to expose the underlying muscular layer for a width of approximately 1cm around the GJA circumference. Following ESD, APC is then applied to the inner and outer mucosal margins of the ESD tract. Finally, endoscopic sutures are then placed in purse string fashion and cinched closed around a 6mm TTS balloon.<br>* Other names: ESD-TORe, endoscopic submucosal dissection TORe;|
| Active Comparator: c-TORe<br>Participants in this arm received the classical or c-TORe procedure | Procedure: c-TORe<br>* The c-TORe will be completed utilizing APC prior to endoscopic suturing. In this approach, the gastric rim of the anastomosis is circumferentially ablated using APC (forced APC, flow of 0.8 L/min and power of 30-70 watts) extending an average of 1-2 cm from the outlet. Following ablation, endoscopic sutures are placed in a purse string fashion within the ablated area and the outlet cinched closed over a 6mm through-the scope (TTS) balloon.<br>* Other names: classic TORe, APC-TORe, argon plasma coagulation TORe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss at 6 months | Percent total body weight loss 6 months following TORe procedure | 6 months from procedure date | 
| Weight loss at 12 months | Percent total body weight loss 12 months following TORe procedure | 12 months from procedure date | 

Secondary Outcome Measures

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