NCT01512563已完成不适用
Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)
Taewoong Medical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2007年2月1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
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Accumulative Patency Rate
研究概览
简要总结
Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.
详细描述
Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
- •Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility
排除标准
- •Patient who have life expectancy under 3 months
- •Patient who have severe metastasis of Liver or whole body
- •Patient who previously had surgical biliary drainage
结局指标
主要结局
Accumulative Patency Rate
时间窗: 6 month
次要结局
- Complications(6 months)
- Accumulative Survival Rate(6 months)
- Possibility of Other Treatment after Obstruction(6 months)
研究者
研究点 (4)
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