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临床试验/NCT01382680
NCT01382680已完成不适用

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

Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2010年10月1日最近更新:
适应症

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

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

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorg Albert

Johann Wolfgang Goethe-University Hospitals

Johann Wolfgang Goethe University Hospital

研究点 (2)

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