Comparing Reduction With ESD- Versus APC-TORe

NCT06131281 | Active Not Recruiting

• 1 other identifier: 23-886
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Roux-en-y Anastomosis Site; Weight Gain

Outcome Measures

Primary Outcomes (2)

• Weight change at 6 months

  Percent total body weight change 6 months following TORe procedure

  6 months from procedure date

• Weight change at 12 months

  Percent total body weight change 12 months following TORe procedure

  12 months from procedure date

Secondary Outcomes (4)

• Technical success

  Day of procedure

• Procedure time

  Day of procedure

• Adverse event rate

  One year from date of procedure

• 5% total body weight loss

  One year from date of procedure

Study Arms (2)

E-TORe

EXPERIMENTAL

Participants in this arm received the E-TORe procedure

Procedure: E-TORe

c-TORe

ACTIVE COMPARATOR

Participants in this arm received the "classical" or c-TORe procedure

Procedure: c-TORe

Interventions

c-TORe PROCEDURE

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.

Also known as: classic TORe, APC-TORe, argon plasma coagulation TORe

c-TORe

E-TORe PROCEDURE

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.

Also known as: ESD-TORe, endoscopic submucosal dissection TORe

E-TORe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen Firkins: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (16)

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• Karmali S, Brar B, Shi X, Sharma AM, de Gara C, Birch DW. Weight recidivism post-bariatric surgery: a systematic review. Obes Surg. 2013 Nov;23(11):1922-33. doi: 10.1007/s11695-013-1070-4.

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• El Ansari W, Elhag W. Weight Regain and Insufficient Weight Loss After Bariatric Surgery: Definitions, Prevalence, Mechanisms, Predictors, Prevention and Management Strategies, and Knowledge Gaps-a Scoping Review. Obes Surg. 2021 Apr;31(4):1755-1766. doi: 10.1007/s11695-020-05160-5. Epub 2021 Feb 8.

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• Athanasiadis DI, Martin A, Kapsampelis P, Monfared S, Stefanidis D. Factors associated with weight regain post-bariatric surgery: a systematic review. Surg Endosc. 2021 Aug;35(8):4069-4084. doi: 10.1007/s00464-021-08329-w. Epub 2021 Mar 1.

  PMID: 33650001 BACKGROUND

• Bastos EC, Barbosa EM, Soriano GM, dos Santos EA, Vasconcelos SM. Determinants of weight regain after bariatric surgery. Arq Bras Cir Dig. 2013;26 Suppl 1:26-32. doi: 10.1590/s0102-67202013000600007. English, Portuguese.

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• Runge TM, Jirapinyo P, Chan WW, Thompson CC. Dysphagia predicts greater weight regain after Roux-en-Y gastric bypass: a longitudinal case-matched study. Surg Obes Relat Dis. 2019 Dec;15(12):2045-2051. doi: 10.1016/j.soard.2019.06.041. Epub 2019 Jul 9.

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• Abu Dayyeh BK, Lautz DB, Thompson CC. Gastrojejunal stoma diameter predicts weight regain after Roux-en-Y gastric bypass. Clin Gastroenterol Hepatol. 2011 Mar;9(3):228-33. doi: 10.1016/j.cgh.2010.11.004. Epub 2010 Nov 17.

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• Jense MTF, Palm-Meinders IH, Sigterman-Nelissen R, Boerma EG, Liem RSL, Swank DJ, Greve JWM. The Benefits of Banded over Non-banded Roux-en-Y Gastric Bypass in Patients with Morbid Obesity: a Multi-center Study. Obes Surg. 2022 Jun;32(6):1856-1863. doi: 10.1007/s11695-022-06024-w. Epub 2022 Apr 2.

  PMID: 35366739 BACKGROUND

• 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.

  PMID: 23567348 BACKGROUND

• Jirapinyo P, Kumar N, AlSamman MA, Thompson CC. Five-year outcomes of transoral outlet reduction for the treatment of weight regain after Roux-en-Y gastric bypass. Gastrointest Endosc. 2020 May;91(5):1067-1073. doi: 10.1016/j.gie.2019.11.044. Epub 2019 Dec 7.

  PMID: 31816315 BACKGROUND

• Schulman AR, Kumar N, Thompson CC. Transoral outlet reduction: a comparison of purse-string with interrupted stitch technique. Gastrointest Endosc. 2018 May;87(5):1222-1228. doi: 10.1016/j.gie.2017.10.034. Epub 2017 Nov 3.

  PMID: 29108984 BACKGROUND

• Dhindsa BS, Saghir SM, Naga Y, Dhaliwal A, Ramai D, Cross C, Singh S, Bhat I, Adler DG. Efficacy of transoral outlet reduction in Roux-en-Y gastric bypass patients to promote weight loss: a systematic review and meta-analysis. Endosc Int Open. 2020 Oct;8(10):E1332-E1340. doi: 10.1055/a-1214-5822. Epub 2020 Sep 22.

  PMID: 33015335 BACKGROUND

• Jirapinyo P, de Moura DTH, Thompson CC. Endoscopic submucosal dissection with suturing for the treatment of weight regain after gastric bypass: outcomes and comparison with traditional transoral outlet reduction (with video). Gastrointest Endosc. 2020 Jun;91(6):1282-1288. doi: 10.1016/j.gie.2020.01.036. Epub 2020 Jan 31.

  PMID: 32007520 BACKGROUND

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

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• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

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  PMID: 31078660 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Stephen Firkins, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to which procedure they received. The physician performing the procedure cannot be blinded to the procedure type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director of Bariatric Endoscopy

Model Details: Prospective, single-blinded, randomized controlled trial

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)