search
Back to results

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

Primary Purpose

Liver Transplantation, Obesity, Bariatric Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endoscopic sleeve gastroplasty (ESG)
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Liver transplant obese candidates

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
February 27, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05760235
Brief Title
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates
Acronym
ESGiTX
Official Title
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Obesity, Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liver transplant obese candidates
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sleeve gastroplasty (ESG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transplant list inclusion
Description
number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Marrone
Phone
+390630157779
Email
giuseppe.marrone@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Marrone
Phone
+39 0630157779
Email
giuseppe.marrone@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs