ESD-TORe vs APC-TORe for Obesity After Gastric Bypass

(CREATORe Trial)

Recruiting in Palo Alto (17 mi)

Overseen by C. Roberto Simons-Linares, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Carlos Roberto Simons-Linares

Must not be taking: Anticoagulants, P2Y12 inhibitors

Disqualifiers: Prior revision, Uncontrolled reflux, Pregnancy, Insulin-dependent diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants stop using anticoagulation therapy or P2Y12 inhibitors around the time of the procedure. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment ESD-TORe vs APC-TORe for obesity after gastric bypass?

Research shows that transoral outlet reduction (TORe) is effective in managing weight regain after Roux-en-Y gastric bypass, with techniques like full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe) being commonly used. However, while TORe can induce short- and mid-term weight loss, its effects may diminish over time, suggesting it may need to be repeated for sustained results. ^{1 2 3 4 5}

How does the treatment ESD-TORe vs APC-TORe for obesity after gastric bypass differ from other treatments?

The ESD-TORe and APC-TORe treatments are unique because they are minimally invasive endoscopic procedures specifically designed to manage weight regain after Roux-en-Y gastric bypass by reducing the size of the stomach outlet. Unlike other weight loss treatments, these procedures focus on revising the previous gastric bypass surgery to help patients maintain weight loss. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults who had Roux-en-Y gastric bypass surgery but gained weight back. They must have a widened gastrojejunal connection seen on endoscopy and be getting standard obesity care at the study's GI Bariatric Endoscopy program.

Inclusion Criteria

I am receiving TORe for obesity as part of the GI Bariatric Endoscopy program.

I had Roux-en-Y gastric bypass surgery and have regained weight.

My stomach connection to the small intestine is enlarged.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the c-TORe or E-TORe procedure to assist with weight loss

Day of procedure

1 visit (in-person)

Follow-up

Participants are monitored for weight change and adverse events after the procedure

12 months

Regular follow-up visits

Treatment Details

Interventions

• c-TORe (Procedure)
• E-TORe (Procedure)

Trial Overview The trial compares two ways of doing the TORe procedure to see which one leads to more weight loss and is safer. Participants will randomly receive either c-TORe or E-TORe, with all other aspects of care being identical.

Participant Groups

Group I: E-TORe Experimental Treatment 1 Intervention

Participants in this arm received the E-TORe procedure

Group II: c-TORe Active Control 1 Intervention

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

c-TORe is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Transoral Outlet Reduction for:

• Weight regain after Roux-en-Y gastric bypass surgery

🇪🇺 Approved in European Union as TORe for:

• Weight regain after gastric bypass surgery

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Foundation Cleveland, OH

Who Is Running the Clinical Trial?

Carlos Roberto Simons-Linares Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Heterozygous Variants in the Leptin-Melanocortin Pathway on Transoral Outlet Reduction After Roux-en-Y Gastric Bypass: A Case-Control Study and Review of Literature. [2023] Transoral outlet reduction (TORe) is a safe and effective technique for management of weight regain (WR) after Roux-en-Y Gastric Bypass (RYGB). Carriers of a heterozygous variant in the leptin melanocortin pathway (LMP) have been shown to be at high risk for WR in the mid- and long-term after RYGB. Our case series includes four patients with heterozygous LMP variants and presents novel data on their weight loss after TORe.

2. United States pubmed.ncbi.nlm.nih.gov

Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice. [2023] Transoral outlet reduction (TORe) is a minimally invasive endoscopic revision of Roux-en-Y gastric bypass (RYGB) for weight recurrence; however, little has been published on its clinical implementation in the community setting.

3. United States pubmed.ncbi.nlm.nih.gov

Endoscopic full-thickness suturing plus argon plasma mucosal coagulation versus argon plasma mucosal coagulation alone for weight regain after gastric bypass: a systematic review and meta-analysis. [2021] Endoscopic transoral outlet reduction (TORe) has been used to manage weight regain after Roux-en-Y gastric bypass. We conducted a meta-analysis to summarize the efficacy and safety of the two most commonly used techniques: full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe).

4. Germany pubmed.ncbi.nlm.nih.gov

Long-term follow-up after transoral outlet reduction following Roux-en-Y gastric bypass: Back to stage 0? [2023] Background and study aims  Significant weight regain affects up to one-third of patients after Roux-en-Y gastric bypass (RYGB) and demands treatment. Transoral outlet reduction (TORe) with argon plasma coagulation (APC) alone or APC plus full-thickness suturing TORe (APC-FTS) is effective in the short term. However, no study has investigated the course of gastrojejunostomy (GJ) or quality of life (QOL) data after the first post-procedure year. Patients and methods  Patients eligible for a 36-month follow-up visit after TORe underwent upper gastrointestinal endoscopy with measurement of the GJ and answered QOL questionnaires (RAND-36). The primary aim was to evaluate the long-term outcomes of TORe, including weight loss, QOL, and GJ anastomosis (GJA) size. Comparisons between APC and APC-FTS TORe were a secondary aim. Results  Among 39 eligible patients, 29 returned for the 3-year follow-up visit. There were no significant differences in demographics between APC and APC-FTS TORe groups. At 3 years, patients from both groups regained all the weight lost at 12 months, and the GJ diameter was similar to the pre-procedure assessment. As to QOL, most improvements seen at 12 months were lost at 3 years, returning to pre-procedure levels. Only the energy/fatigue domain improvement was kept between the 1- and 3-year visits. Conclusions  Obesity is a chronic relapsing disease. Most effects of TORe are lost at 3 years, and redilation of the GJA occurs. Therefore, TORe should be considered iterative rather than a one-off procedure.

5. Germany pubmed.ncbi.nlm.nih.gov

Purse-string transoral outlet reduction (TORe) is effective at inducing weight loss and improvement in metabolic comorbidities after Roux-en-Y gastric bypass. [2022] BACKGROUND AND STUDY AIMS : Transoral outlet reduction (TORe), performed using a traditional interrupted or a recently described purse-string suture pattern, is effective at inducing short- and mid-term weight loss in patients with weight regain after Roux-en-Y gastric bypass (RYGB). We aimed to determine the technical feasibility and safety of purse-string TORe and to assess its impact on weight and metabolic profiles.