Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a procedure called endoscopic sleeve gastroplasty (ESG) to help people who are obese and need a liver transplant. The main goal is to see if ESG can help these patients lose enough weight to meet the body mass index (BMI) requirement for being placed on the transplant waiting list, which is a BMI of 35 or higher. The study will follow participants for 12 months to assess their weight loss, quality of life, and any health issues related to obesity.

To participate in this trial, individuals must be adults aged 18 to 70 with a BMI of 35 or higher who are not currently on the liver transplant list due to their weight. Participants will receive the ESG procedure and will be monitored for a year before and after their liver transplant. It's important to note that there are certain health conditions that would exclude someone from joining this study, such as significant liver problems or recent surgeries. Overall, this study aims to find effective ways to help patients lose weight and improve their health before undergoing a liver transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (i.e., age between 18 and 70 years).
• • BMI ≥ 35 kg/m²;
• • Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
• • Signed informed consent.
• Exclusion Criteria:
• • Clinically significant portal hypertension at upper endoscopy: F3 or F1/F2 with red signs oesophageal varices, gastric varices or severe hypertensive gastropathy;
• • Upper gastro-intestinal bleeding (gastric or esophageal) in the previous six months;
• • CHILD C class;
• • Clinically or ultrasound-detected ascites in the 15 days before the procedure. Only mild ascitic effusion in the pelvis will be accepted;
• • Spontaneous bacterial peritonitis in the previous 6 months;
• • Hepatocellular carcinoma with extra hepatic spread;
• • Previous stomach, oesophagus or duodenum surgery;
• • Technical non-feasibility in the opinion of the endoscopist;
• • Clinical signs of active infection;
• • Unstable cardiac disease or chronic heart failure;
• • Platelet count less than 70.000;
• • International Normalized Ratio ≥ 1,5;
• • Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
• • Acute liver failure;
• • Easy to bleed during diagnostic endoscopy;
• • Active drugs or alcohol abuse;
• • Pregnancy, lactation (desire to become pregnant during study duration);
• • Enrolment in other clinical studies;
• • Contraindication to general anaesthesia;
• • Contraindication to endoscopic procedure;
• • Other conditions to exclude the subject in investigators opinion;
• • Refusal to sign informed consent.