Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- complete biliary stone clearance
研究概览
简要总结
The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.
详细描述
same as brief summary
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •18 years and older
- •Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy.
- •Stone can be bridged by the metal stent
- •Subject must be able to give informed consent.
排除标准
- •Any contraindication to ERCP
- •Patient refuses consent for the study.
结局指标
主要结局
complete biliary stone clearance
时间窗: 12 months
This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions
次要结局
- other techniques used for stone clearance(12 months)
