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

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 Overview

• Status: Recruiting
• Conditions: Liver Transplantation; Obesity; Bariatric Surgery
• Intervention / Treatment: Procedure: Endoscopic sleeve gastroplasty (ESG)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Marrone; Phone Number: +390630157779; Email: giuseppe.marrone@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Gemelli IRCCS
      • Contact: Giuseppe Marrone; Phone Number: +39 0630157779; Email: giuseppe.marrone@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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)

Procedure: Endoscopic sleeve gastroplasty (ESG); ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free15. The procedure will be performed with the patient in supine position. Carbon dioxide will be blown to stretch the gastric lumen. An initial endoscopic evaluation will be performed immediately to confirm the absence of any contraindication to ESG before suturing. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplant list inclusion	number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 4903

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No