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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 27, 2024

Keywords

ClinConnect Summary

The ESG Integrity Study is a clinical trial that is exploring how a type of medication called proton pump inhibitors (PPIs) affects the healing and structure of a weight loss procedure known as Endoscopic Sleeve Gastroplasty (ESG). This study is designed for adults aged 20 to 65 who are considered obese, with a body mass index (BMI) between 30 and 45. To participate, individuals should not have certain health issues, such as recent stomach problems or serious heart conditions, and they should be willing to follow the study guidelines.

Participants in the trial will be divided into two groups. One group will stop taking PPIs 24 hours after their ESG procedure, while the other group will take a specific dose of Esomeprazole (a type of PPI) for eight weeks following the procedure. Throughout the trial, participants will be monitored to see how the use of PPIs affects their recovery and the integrity of the ESG. This study is currently recruiting participants, and it aims to help improve understanding of how medications can impact weight loss surgery outcomes.

Gender

ALL

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.