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

NCT ID: NCT06283381

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-06-30

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: experimental group

no administration of Esomeprazole or any other proton pump inhibitor after the Endoscopic Sleeve Gastroplasty

Group Type: EXPERIMENTAL

Esomeprazole

Intervention Type: DRUG

oral administration, tablets, 40 mg

Arm B: standard of care group

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

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

oral administration, tablets, 40 mg

Interventions

Esomeprazole

oral administration, tablets, 40 mg

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

IVO BOSKOSKI

Role: primary

ivo.boskoski@policlinicogemelli.it

+390630155701

Other Identifiers

4264

Identifier Type: -

Identifier Source: org_study_id