Comparison of the Use of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil Guide Wire With a Nitinol Wire in Patients With Stenosis of the Bile Ducts in ERCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Number of guidewires per ERCP session
研究概览
简要总结
In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.
详细描述
This is a randomized, monocentric study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data)
排除标准
- •Operatively alternated anatomy of the patient.
- •Intervention of the pancreatic duct.
结局指标
主要结局
Number of guidewires per ERCP session
时间窗: Within the same ERCP session (day 1)
次要结局
- Time of ERCP session(day 1)
- Treatment aim(day 1)
研究者
Jorg Albert
Johann Wolfgang Goethe-University Hospitals
Johann Wolfgang Goethe University Hospital
