Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass (ARG-BP)

Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass. Monocentric, Comparative, Randomized, Open Study.

Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Argon plasma coagulation

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BELLEC-FAGOT; Phone Number: 0637110376; Email: mbellecfagot@vivalto-sante.com
• Study Contact Backup: Name: Adrien STERKERS, MD; Email: asterkers@vivalto-sante.com

Study Locations

• France
  • Saint-gregoire, France, 35760
    • Recruiting
    • CHP Saint-Grégoire
    • Contact: Muriele BELLEC-FAGOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be between 18 and 65 years old.
• Have had a gastric bypass in Y more than 2 years ago
• Have a weight regain of more than 10% of the lowest weight after the first intervention.
• Have benefited from a multidisciplinary medico-psychological reassessment.
• Understand the interest of the study and agree to long-term follow-up.
• Agree to be included in the study and have signed a consent form in a free and informed manner.
• Be affiliated with health insurance.
• For female patients of childbearing potential, have an effective method of contraception

Exclusion Criteria:

• Presence of a disease unrelated to obesity that is life-threatening.
• Pregnancy or wish to become pregnant within the year.
• "Breastfeeding" patients
• Female patients of childbearing age and unable or unwilling to use an effective method of contraception
• Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
• Presence of a psychiatric pathology compromising the proper understanding of the study or patient under guardianship or guardianship.
• Patient not understanding French or unable to give consent.
• Patient already included in a study or in conflict of interest with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APC intervention; In addition to multidisciplinary care (standard care), patients benefit from an Argon Plasma Coagulation (APC) intervention at D0. The APC intervention should be repeted at Month 2 and Month 4.	Procedure: Argon plasma coagulation; On D0, in the operating room, argon plasma coagulation will be performed around the perimeter of the anastomosis for a period of 5 to 10 min under general anesthesia. The removal of the catheter and the endoscope will be carried out under control. Patients will be kept under surveillance the night following the procedure. A liquid diet will be prescribed for 10 days. The follow-up will be carried out on an outpatient basis with a control endoscopy at 2 months, followed by a new procedure in the event of an anastomosis larger than 1.5 cm. A new endoscopic check will be carried out at 4 months if an argon plasma coagulation was performed during the previous check, with a third and last argon plasma coagulation if an anastomosis of more than 1.5 cm persists. The number of procedures will therefore be a maximum of 3. A control endoscopy will be performed at one year for the final control of the anastomosis.
No Intervention: Control; Patients are treated according to standard care (multidisciplinary care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms	The percentage of excess weight loss (PEP%) will be measured according to the formula: PEP% = weight loss in kg * 100 / excess of initial weight. The initial excess weight is defined as the baseline weight - ideal weight.	Day 0 (before the intervention) and Months 12 (one year after Day 0)

Collaborators and Investigators

• Sponsor: Saint-Gregoire Private Hospital Center

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A02992-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No