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

(CREATORe Trial)

Overseen By C. Roberto Simons-Linares, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day of procedure

70 Participants Needed

Trial Summary

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}

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.

Research Team

C. Roberto Simons-Linares, MD

Principal Investigator

The Cleveland Clinic

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.

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
• E-TORe

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

Who Is Running the Clinical Trial?

Carlos Roberto Simons-Linares

Lead Sponsor

Trials

2

Recruited

190+

Findings from Research

Transoral outlet reduction (TORe) is a safe and effective procedure for managing weight regain after Roux-en-Y Gastric Bypass (RYGB), particularly in patients with genetic variants.

In a study of 14 patients, those with a heterozygous variant in the leptin melanocortin pathway (LMP) lost significantly less weight after TORe compared to non-carriers, indicating that genetic factors may influence the efficacy of this intervention.

NCBI (Pubmed)

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. Gala, K., Ghusn, W., Fansa, S., et al.[2023]

Transoral outlet reduction (TORe) is a safe and effective procedure for adults experiencing weight recurrence after Roux-en-Y gastric bypass, showing a total body weight loss of 17.3% at twelve months in a study of 284 patients.

The procedure had a low complication rate, with only 3.9% of patients experiencing outlet stenosis, which was successfully treated, and a serious adverse event rate of just 0.4%, indicating good safety in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice. Maselli, DB., Chittajallu, V., Wooley, C., et al.[2023]

Both full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe) are effective in achieving significant weight loss after Roux-en-Y gastric bypass, with comparable results at 3, 6, and 12 months.

The safety profiles of both techniques are high, with only one severe adverse event reported for APMC-TORe and none for ft-TORe, indicating that both methods are safe options for managing weight regain.

NCBI (Pubmed)

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. Jaruvongvanich, V., Vantanasiri, K., Laoveeravat, P., et al.[2021]

In a study of 29 patients who underwent transoral outlet reduction (TORe) after Roux-en-Y gastric bypass, significant weight regain occurred by the 3-year follow-up, with patients regaining all weight lost at 12 months and the gastrojejunostomy diameter returning to pre-procedure sizes.

Quality of life improvements observed at 12 months were mostly lost by the 3-year mark, indicating that TORe may need to be repeated over time to maintain its benefits, as only the energy/fatigue domain showed sustained improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after transoral outlet reduction following Roux-en-Y gastric bypass: Back to stage 0? Brunaldi, VO., Peixoto de Oliveira, GH., Kerbage, A., et al.[2023]

Purse-string transoral outlet reduction (TORe) is a technically feasible and safe procedure for patients who have regained weight after Roux-en-Y gastric bypass, with a 100% technical success rate in 260 procedures.

Patients experienced significant weight loss, averaging 9.6% at 6 months and 8.4% at 12 months, along with improvements in metabolic health markers such as blood pressure and hemoglobin A1c.

NCBI (Pubmed)

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. Jirapinyo, P., Kröner, PT., Thompson, CC.[2022]

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]

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]

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]

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]

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]