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

NCT06283381 | Recruiting Phase 4

• 1 other identifier: 4264
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)

  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).

  6 months

Study Arms (2)

Arm A: experimental group

EXPERIMENTAL

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

Drug: Esomeprazole

Arm B: standard of care group

ACTIVE COMPARATOR

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

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

oral administration, tablets, 40 mg

Arm A: experimental group; Arm B: standard of care group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: February 1, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IT (1)