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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country24 target enrollmentOctober 13, 2022

ConditionsLiver Transplantation Obesity Bariatric Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Liver Transplantation
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 24
Locations: 1
Primary Endpoint: Transplant list inclusion
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question[s] it aims to answer are:

Is the procedure effective in reducing BMI to the target level in 12 months?
Which is the effect on weight loss, quality of life and obesity-related comorbidities?

Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation

Registry

clinicaltrials.gov

Start Date

October 13, 2022

End Date

November 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Sponsor

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;