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

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 13, 2022

Primary Completion Date

October 31, 2024

Study Completion Date

November 30, 2024

Conditions
Liver TransplantationObesityBariatric Surgery
Interventions
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.

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER