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临床试验/NCT01239056
NCT01239056已完成不适用

Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent

University of Florida1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年8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
22
试验地点
1
主要终点
Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen

研究概览

简要总结

The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.

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

  • Subject is 18 years or older
  • Subject has pancreatic pseudocyst
  • Subject has medical indication for drainage of the pancreatic pseudocyst
  • Subject must be able to give informed consent

排除标准

  • Any contraindication to endoscopic pseudocyst drainage
  • Subject is unable to give informed consent

结局指标

主要结局

Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen

时间窗: baseline

Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst . Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst.

次要结局

  • Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).(6 to 12 weeks after baseline)
  • Adverse Events(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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