NCT05760235RecruitingNot Applicable
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 IRCCS2 sites in 1 country24 target enrollmentStarted: October 13, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Transplant list inclusion
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Transplant list inclusion
Time Frame: 12 months
number of patients who achieve a BMI \< 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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