Clinical trial NCT06283381: The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
Official title: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:

* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).

The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG


Eligibility criteria: Inclusion Criteria:

* Age 20 to 65 years
* BMI between 30 to 45 kg/m2
* Willingness to participate in the study and ability to comply and understand the study protocol.

Exclusion Criteria:

* Active gastric gastro-duodenal during the last 6 months
* Helicobacter pylori infection.
* Organic or motility disorder of the stomach and / or esophagus
* Anticoagulant treatment
* Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
* Ongoing or active malignancy during the last 5 years.
* Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
* Drug or alcohol abuse
* Bulimic or binge eating pattern
* Continuous glucocorticoid or anti-inflammatory treatment
* Uncontrolled thyroid disease.
* Pregnancy, breastfeeding
* Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
* Hiatal hernia ≥ 5 cm
* Known allergy or hypersensitivity to the active substance or any of the other excipients
* Liver cirrhosis of any Child-Phugh stage or MELD\> 15
* Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation)
* Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
* Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

Primary outcomes:
measure: The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References: