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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 di

Первичные конечные точки

• Kidney transplant list inclusion [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Идентификаторы

NCT: NCT05917795 · 5764

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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