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CREATORe: Comparing Reduction With ESD- Versus APC-TORe

Sponsor
Carlos Roberto Simons-Linares (Other)
Overall Status
Recruiting
CT.gov ID
NCT06131281
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: E-TORe
  • Procedure: c-TORe
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, single-blinded, randomized controlled trialProspective, single-blinded, randomized controlled trial
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to which procedure they received. The physician performing the procedure cannot be blinded to the procedure type.
Primary Purpose:
Treatment
Official Title:
Comparing Outcomes of Classic Transoral Outlet Reduction (TORe) Versus Endoscopic Submucosal Dissection-TORe: A Randomized Controlled Trial
Actual Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: E-TORe

Participants in this arm received the E-TORe procedure

Procedure: E-TORe
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.
Other Names:
  • ESD-TORe, endoscopic submucosal dissection TORe

    		•
    Active Comparator: c-TORe

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

    Procedure: c-TORe
    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.
    Other Names:
  • classic TORe, APC-TORe, argon plasma coagulation TORe

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight loss at 6 months [6 months from procedure date]

      Percent total body weight loss 6 months following TORe procedure

    2. Weight loss at 12 months [12 months from procedure date]

      Percent total body weight loss 12 months following TORe procedure

    Secondary Outcome Measures

    1. Technical success [Day of procedure]

      Rates of technical success of the procedure as determined by the experienced endoscopist performing the TORe procedure

    2. Procedure time [Day of procedure]

      Mean time to complete each procedure type

    3. Adverse event rate [One year from date of procedure]

      Rate of adverse events related to each procedure type

    4. 5% total body weight loss [One year from date of procedure]

      Proportion of subjects who achieved at least 5% total body weight loss

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Foundation Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Carlos Roberto Simons-Linares

    Investigators

    • Principal Investigator: C. Roberto Simons-Linares, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Carlos Roberto Simons-Linares, Director of Bariatric Endoscopy, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT06131281
    Other Study ID Numbers:
    • 23-886
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Weight Gain

    Study Results

    No Results Posted as of Nov 14, 2023