Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates (ESGiTXKidney)

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

The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. 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: End Stage Renal Disease; Kidney Transplantation; Obesity, Morbid; Endoscopic Sleeve Gastroplasty
• Intervention / Treatment: Procedure: Endoscopic Sleeve Gastroplasty (ESG)

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

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Ivo Boskoski; Phone Number: +390630156580; Email: ivo.boskoski@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;
• Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate [GFR] <30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible;
• Patients 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:

• Patients on peritoneal dialysis
• Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months;
• Ongoing or active malignancy during the last 5 years
• Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification;
• Previous stomach, oesophagus or duodenum surgery;
• Technical non-feasibility in the opinion of the endoscopist;
• Clinical signs of active infection;
• Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
• Active drugs or alcohol abuse;
• Pregnancy, lactation (desire to become pregnant during study duration);
• Enrolment in other clinical studies;
• Contraindication to general anaesthesia;
• 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: kidney transplant candidates with obesity (BMI > 35 kg/m2); Subjects with an indication to kidney 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 (GIF-H190/GIF-HQ190; Olympus Medical Systems Corp., Tokyo, Japan) 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 free. 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. The final effect of ESG is the creation of a gastric tubule thus reducing the volume of the stomach. After the procedure, the final shape will be evaluated, to examine any gaps that would require additional closure, and to exclude bleedings and/or other complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney 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 kidney transplant list	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Obesity; Kidney Failure, Chronic; Obesity, Morbid
• Other Study ID Numbers: 5764

Drug and device information, study documents

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