National Registry of Obesity Treatment by Endosleeve
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSociété Française d'Endoscopie Digestive
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age over 18 years;
Patient with a body mass index (BMI) ≥ 30 kg/m²;
Signed informed consent
Disqualifiers
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;
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)
Procedure/SurgeryThe 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 about 45 minutes and includes measures to prevent vomiting. Endomina™ is a single-use device that captures the gastric mucosa to create successive plications, allowing for effective suturing along the greater curvature of the stomach.
Treatment groups
354 Participants
are divided into 1 treatment groupGroup A: Endoscopic sleeve gastroplasty1 intervention
Trial outcomes
Primary outcomes
1
Measurement of total weight loss (TWL) in % 5 years afther endosleeve
To determine the proportion of patients who met the PIVI criteria after endosleeve without additional techniques
Time frame
5 yearsSecondary outcomes
1
Measurement of total weight loss (TWL) in %
Determine total weight loss (TWL) afther endosleeve at 12, 24 months,
Time frame
12 et 24 months2
Measurement excess weight loss after the endosleeve intervention.
Determine excess weight loss (EWL) after the endosleeve intervention, with positivity established by the PIVI criteria (EWL \> 25% at 12 months), and evaluate the long-term evolution of this EWL
Time frame
12, 24 months, and 5 years3
Measurement of the percentage of postoperative complications according to the AGREE classification
The safety of this procedure will be evaluated by recording complications perioperatively (Day 1) and post-procedure (Day 30) according to the AGREE criteria and using the PIVI criteria (positive if the complication rate is \< 5%).
Time frame
Day 1 and Day 30.4
Measurement of remission (or regression) of pre-existing comorbidities
Determine the impact on pre-existing metabolic comorbidities : 1. Diabetes remission = HbA1C \< 6.5%, 3 months after discontinuation of all treatment / Regression or improvement of diabetes involving a decrease of more than 0.5% in HbA1C according to recognized criteria 2. Hypertension = Systolic blood pressure (SBP) \< 140 mmHg and/or Diastolic blood pressure (DBP) \< 90 mmHg without any treatment / Decrease in the number of therapeutic classes; 3. Obstructive Sleep Apnea Syndrome (OSAS) = Number of apneas less than 5 without equipment / Decrease in OSAS stage = mild (5 to 15 per hour), moderate (15 to 30), or severe (more than 30) with or without equipment; 4. Steatohepatitis = quantification by MRI of the % of fat in the liver with a decrease of more than 30%; 5. Dyslipidemia = normalization or improvement of LDL cholesterol and triglyceride levels without the addition of new drug therapies.
Time frame
12 months, 24 months, and 5 years.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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