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The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-02-01
Completion Date
2026-06-30
Last Updated
2024-02-28
Healthy Volunteers
No
Conditions
Interventions
Esomeprazole
oral administration, tablets, 40 mg
Locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy