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临床试验/NCT01675908
NCT01675908已完成不适用

Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

AdventHealth2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2012年8月22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
AdventHealth
入组人数
46
试验地点
2
主要终点
Complications related to stent dysfunction

研究概览

简要总结

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

详细描述

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Complications related to stent dysfunction

时间窗: 30 days

Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

次要结局

  • Procedural complications(30 days)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (2)

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