Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Migration rate of FCSEMS
研究概览
简要总结
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.
We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.
排除标准
- •Expected life span ≤6 months
- •Considering tumor resection within 6 months
- •Failed CBD cannulation
- •Hilar stricture (Bismuth II, III and IV)
- •CBD dilating by a balloon catheter with diameter≥8mm
- •Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
- •Maximal CBD diameter ≤6mm
- •Pregnancy or lactation
- •Unable to provide informed consent
结局指标
主要结局
Migration rate of FCSEMS
时间窗: 6 months
The proportion of patients who had stent migration after placing FCSEMS, which was defined as radiological or endoscopic evidence of distal or proximal migration within 6 months after placing FCSEMS.
次要结局
- Complications related to stent removal(6 months)
- Proximal migration rate(6 months)
- Distal migration rate(6 months)
- Rate of cholangitis after FCSEMS placement(6 months)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China