跳至主要内容
临床试验/NCT02166970
NCT02166970已完成不适用

Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study

Soon Chun Hyang University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Reintervention rate when stents occluded

研究概览

简要总结

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

详细描述

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.

However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.

The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.

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
Single (Care Provider)

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

  • age > 18 years
  • inoperable hilar malignancy

排除标准

  • age under 18 years
  • uncontrolled coagulopathy
  • inability to provide informed consent

结局指标

主要结局

Reintervention rate when stents occluded

时间窗: 2 years

When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.

次要结局

  • Technical success of single or multiple stents(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae Hoon Lee

Professor

Soon Chun Hyang University

研究点 (2)

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