National Registry of Obesity Treatment by Endosleeve

Overview

Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Currently, the prevention of obesity in our Western societies is not effective enough, as the prevalence and incidence of obesity and overweight continue to rise worldwide. In France, the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity, with three authorized methods that have shown sufficient evidence: gastric banding, sleeve gastrectomy (or longitudinal sleeve gastrectomy), and Roux-en-Y gastric bypass. With the advent of organ-preserving interventional endoscopy, the systematic use of these surgical methods, although effective for total weight loss and excess weight loss, raises questions. Indeed, these new therapeutic endoscopic approaches, which are less invasive, less costly, and respectful of anatomy, currently show convincing cohort results in the short term (12 to 24 months) and require confirmation of their effectiveness and safety in the long term (5 years) so that they can become first-line therapeutic methods in the near future. At the request of the HAS in its self-referral of 2020 and then in 2022, this prospective registry aims to confirm the effectiveness and safety of the endosleeve (or endoscopic sleeve) in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment.

Interventions

• Procedure Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)
  The patient will undergo therapeutic endoscopy under general anesthesia, either as outpatient or inpatient care, based on the recommendations of the investigating physician, taking into account anesthetic risks and comorbidities. Two CE-marked gastric suturing devices may be used at the discretion of the investigating center based on their practices OverStich™ allows for tissue fixation via a gastroscope, creating a durable suture through a transabdominal fixation technique. The procedure lasts

Primary outcome measures

• Measurement of total weight loss (TWL) in % 5 years afther endosleeve [Time frame: 5 years]

Secondary outcome measures (11)

• Measurement of total weight loss (TWL) in % [Time frame: 12 et 24 months]
• Measurement excess weight loss after the endosleeve intervention. [Time frame: 12, 24 months, and 5 years]
• Measurement of the percentage of postoperative complications according to the AGREE classification [Time frame: Day 1 and Day 30.]
• Measurement of remission (or regression) of pre-existing comorbidities [Time frame: 12 months, 24 months, and 5 years.]
• Occurrence of metabolic comorbidities [Time frame: 12 months, 24 months, and 5 years]
• Outpatient procedures [Time frame: 30 days]
• Bariatric procedures performed following the initial intervention [Time frame: Day 1 and Day 30.]
• Conversion rates in bariatric surgery and their feasibility [Time frame: 3 years and 5 years]
• Predictive factors for response, weight regain, and plateau at the EndoSleeve [Time frame: 3 months, 6 months and 1 year]
• Sequence of bariatric procedures that led to the best weight response [Time frame: 5 years]
• Measurement of the improvement in quality of life. [Time frame: 12 months , 24 months, and at 5 years of follow-up.]

Eligibility criteria

Inclusion criteria

• Age over 18 years;
• Patient with a body mass index (BMI) ≥ 30 kg/m²;
• Signed informed consent

Exclusion criteria

• Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
• Presence of an ulcer in the gastric body or fundus;
• Achalasia, severe esophagitis (Los Angeles grade C or D);
• ENT or esophageal malformation;
• Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
• Congestive gastropathy, gastric polyposis, gastric or esophageal varices, risk of gastric tumor disease due to personal or family history;
• Positive Helicobacter pylori status with failed eradication treatments;
• Uncontrolled or severe eating disorder or psychiatric illness;
• Substance abuse or chronic alcoholism;
• Severe renal insufficiency (stage 4 or 5), Cirrhosis Child B or C;
• Anticoagulant or antiplatelet treatment that cannot be stopped or replaced according to international recommendations (ESGE 2021);
• Coagulation or hemostasis disorders (PT < 60%, platelets < 60,000/mm³);
• Mental deficiency of the subject making participation in the trial impossible;
• Patient not affiliated with a social security scheme;
• Pregnant women, breastfeeding individuals;
• Inability to understand or sign the informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06657339 · SFED-153

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗