Actively Recruiting
The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-28
40
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 to 65 years
- Body mass index (BMI) between 30 to 45 kg/m2
- Willingness to participate and ability to comply with the study protocol
You will not qualify if you...
- Active gastric or gastro-duodenal ulcers in the last 6 months
- Helicobacter pylori infection
- Organic or motility disorders of the stomach or esophagus
- Anticoagulant treatment
- Previous bariatric surgery or surgery on esophagus, stomach, or duodenum
- Ongoing or active malignancy in the last 5 years
- Myocardial infarction in the past 6 months or heart failure class III or IV
- Drug or alcohol abuse
- Bulimic or binge eating patterns
- Continuous glucocorticoid or anti-inflammatory treatment
- Uncontrolled thyroid disease
- Pregnancy or breastfeeding
- Psychiatric or cooperation problems or low compliance
- Hiatal hernia 5 cm or larger
- Known allergy or hypersensitivity to study drugs
- Liver cirrhosis or MELD score above 15
- Severe chronic kidney failure (eGFR below 30 ml/min/1.73 m2)
- Participation in another clinical trial recently
- Any health issue that risks patient safety as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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