Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates (ESGiTX)
Liver Transplantation, Obesity, Bariatric Surgery
About this trial
This is an interventional treatment trial for Liver Transplantation
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; Internationa 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.
Sites / Locations
- Fondazione Policlinico Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Experimental
Liver transplant obese candidates
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)