Clinical trial NCT06657339: National Registry of Obesity Treatment by Endosleeve
Official title: National Registry of Obesity Treatment by Endosleeve
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity
Keywords: Endosleeve
Endoscopic gastroplasty
Endoscopic suture
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any referred patient with obesity and a BMI \> 30 kg/m² who meets the inclusion criteria and is considered suitable for therapeutic management of obesity will be invited to participate in the study at the investigating centers

Brief summary: 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.


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.

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