NCT07675122招募中不适用
Endoscopic Duodenal-jejunal Bypass Sleeve for Treatment of Obesity and Metabolic Syndrome - a Multicenter Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Excess body weight loss (%EBWL)
研究概览
简要总结
This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity
详细描述
This is a prospective, single-arm study enrolling individuals with obesity. Participants will receive 3 months implantation of duodenal-jejunal bypass sleeve (DJBS). They will be followed for another 9 months after removal of DJBS to assess the outcomes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome
排除标准
- •Patients who have lost more than 5 kg of weight in the past three months
- •Patients who have used glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the past three months
- •Patients who are currently taking weight loss drugs such as orlistat
- •Those who have taken antiplatelet drugs or anticoagulant drugs such as aspirin in the past month
- •iron deficiency or iron deficiency anemia
- •Gastrointestinal malformations, such as patients with gastrointestinal atresia or other patients who will cause gastrointestinal implantation failure
- •Those with a history of cholecystitis and liver abscess
- •There is a known infection, and the type of disease and the severity of the infection are not suitable for use by clinicians
- •coagulation dysfunction;
- •Severe liver and kidney dysfunction, AST /ALT > 2.5 times, total bilirubin > 35 μmol/L, blood creatinine concentration greater than 180 μmol/L
- •Patients with ASA IV & V
- •Drug or alcohol abuse addiction or suffering from uncontrollable mental illness
- •Duodenal bulb ulcer, gastric ulcer or previous and existing pancreatitis
- •Coronary heart disease, angina, cardiac function grade III or above, or pulmonary dysfunction
- •Patients who have undergone ERCP before
- •Patients with potential bleeding or telangiectasia in the stomach, esophagus, small intestine and other parts
- •Have a history of systemic lupus erythematosus, scleroderma
- •Those who have contraindications to endoscopy (judged by clinicians)
- •Pregnant women or those who are preparing to become pregnant
- •Those who are allergic to nickel-titanium
- •Any other situation that the clinician deems unsuitable for participation in this product
研究组 & 干预措施
Duodenal-jejunal bypass sleeve (DJBS)
Experimental
3 months implantation of DJBS
干预措施: Implantation of duodenal-jejunal bypass sleeve (Procedure)
结局指标
主要结局
Excess body weight loss (%EBWL)
时间窗: 12 months post-procedure
Percent excess body weight loss (%EBWL) from baseline to Month 12
次要结局
- Incidence of adverse events(within 30 days post-procedure)
- Body fat percentage(12 months post-procedure)
- Duodenal and faecal microbiome(12 months post-procedure)
- Improvement of liver steatosis(12 months post-procedure)
- Improvement of liver fibrosis(12 months post-procedure)
- Change in Quality of Life(12 months post-procedure)
- HbA1c(12 months post-procedure)
- Duodenal mucosal changes(12 months post-procedure)
研究者
Stephen KK Ng
Principal Investigator
Chinese University of Hong Kong
研究点 (4)
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