Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- technical success rate
研究概览
简要总结
Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS
排除标准
- •< 18 years old
- •refusal to participate
结局指标
主要结局
technical success rate
时间窗: Day 1
Technical success was defined as the ability to correctly deploy the Hot AXIOS stent between the common bile duct and the duodenal bulb with visualization of bile flow
次要结局
- Clinical success(Day 28)
- Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.(Year 1)
- Periprocedural adverse events: adverse events that occur during the procedure(Day 1)
- short-term adverse events(Day 7)
- Six month stent patency rate(Month 6)