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临床试验/NCT00919074
NCT00919074已完成不适用

Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation: a Randomized Clinical Trial

Washington University School of Medicine5 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
5
主要终点
Cannulation success rate

研究概览

简要总结

This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First time ERCP

排除标准

  • Successful bile duct cannulation within six minutes
  • Planned pancreatic duct therapy
  • Planned pancreatobiliary manometry
  • Prior successful ERCP

结局指标

主要结局

Cannulation success rate

时间窗: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure

次要结局

  • Complication rate(One week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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