Gastric Recalibration After Endoscopic Sleeve Gastroplasty (ESG-IRM)

IHU Strasbourg

Status: Enrolling

Conditions: Morbid Obesity

Treatments: Procedure: Endoscopic placement of additional sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT04945473

20-006

Details and patient eligibility

About

Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.

Full description

Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 to 75
• Patients with morbid obesity (BMI≥ 30 with comorbidities or> 40)
• Patients with obesity for more than 2 years
• Failure of medical treatment of obesity
• Patients who may benefit from general anaesthesia
• Patient able to participate in all aspects of the study and that agree to comply with all study requirements, for the duration of the study. This includes the availability of reliable transportation and sufficient time to attend all follow-up visits.
• Patient able to fully understand the study and ready to give consent to participate to the study.
• Patient affiliated to the French social security system

Exclusion criteria

• Patient with a contraindication to perform an ESG
• Patient with a history of previous bariatric, gastric or esophageal surgery.
• Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
• Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
• Patient with unstable and precarious state of health, as determined and assessed by the investigator.
• Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
• Patient in exclusion period (determined by a previous or ongoing study)
• Patient under legal protection
• Patient under guardianship or curatorship
• Patients with a BMI less than 30 at 6 months after ESG. These patients will not be candidate for revision regardless of the randomization group.
• Patients with a contraindication to MRI may be included in the study and will follow the "No Imaging" study design.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Revision

Experimental group

Description:

BMI≥30 or total weight loss (TBWL) \< 10% and relaxation of gastric tubulisation at 6 months after ESG. Additional stitches will be placed during the follow-up gastroscopy at 6 months.

Treatment:

Procedure: Endoscopic placement of additional sutures

Without revision

No Intervention group

Description:

The control gastroscopy will be performed without any additional procedure (no additional stitches).