Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Kidney transplant list inclusion
Study Overview
Brief Summary
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 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;
- •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. -
Outcomes
Primary Outcomes
Kidney 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 kidney transplant list
Secondary Outcomes
No secondary outcomes reported