NCT05760235Unknown不适用
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年10月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Transplant list inclusion
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •International 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.
研究组 & 干预措施
Liver transplant obese candidates
Experimental
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)
干预措施: Endoscopic sleeve gastroplasty (ESG) (Procedure)
结局指标
主要结局
Transplant list inclusion
时间窗: 12 months
number of patients who achieve a BMI \< 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list
次要结局
未报告次要终点
研究者
研究点 (1)
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