Evaluating a procedure to help obese liver transplant candidates lose weight

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

This study is testing if a weight-loss procedure called endoscopic sleeve gastroplasty can help obese people who need a liver transplant lose enough weight to qualify for the surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Roma, Lazio)
• Trial ID: NCT05760235 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the effectiveness of endoscopic sleeve gastroplasty (ESG) in reducing body mass index (BMI) in obese patients who require liver transplantation. Participants will undergo the ESG procedure and will be monitored for 12 months to determine if they can achieve the necessary BMI reduction to qualify for the transplant waiting list. The study will also evaluate the impact of weight loss on quality of life and obesity-related health issues. Follow-up will continue for an additional 12 months post-transplantation to gather further data on outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a BMI of 35 kg/m² or higher who need a liver transplant but are currently ineligible due to their weight.

Not a fit: Patients with significant portal hypertension, recent upper gastrointestinal bleeding, or other severe liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could enable obese patients to qualify for liver transplantation by achieving significant weight loss.

How similar studies have performed: While ESG is a recognized bariatric procedure, this specific application for liver transplant candidates is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Roma, Lazio

• Fondazione Policlinico Gemelli IRCCS — Roma, Lazio, Italy (RECRUITING)

Study contacts

• Study coordinator: Giuseppe Marrone

Conditions: Liver Transplantation, Obesity, Bariatric Surgery