The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty

Phase 4

Recruiting

• Conditions: Obesity
• Interventions: Drug: Esomeprazole

• Registration Number: NCT06283381
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-01-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: experimental group	Esomeprazole	no administration of Esomeprazole or any other proton pump inhibitor after the Endoscopic Sleeve Gastroplasty
Arm B: standard of care group	Esomeprazole	administration of Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for another 4 weeks after the Endoscopic Sleeve Gastroplasty

Primary Outcome Measures

Name	Time	Method
The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)	6 months	The structural integrity of the ESG will be defined as opened (all stitches loose), partially intact (at least one stitch loose), or intact (all stitches tight).

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy