跳至主要内容
临床试验/NCT01475864
NCT01475864撤回不适用

Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents

University of Florida0 个研究点开始时间: 2011年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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