NCT01869894已完成不适用
A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Median patency duration
研究概览
简要总结
Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who had malignant biliary obstruction
排除标准
- •The patients who had resectable biliary malignancy
- •The patients who had hilar obstruction
- •The patients who had duodenal obstruction
- •The patients who had other malignancy which is not related to biliary obstruction
- •The patients who had uncontrolled infection
- •The patients who had poor performance (ECOG =3 or 4)
- •The patients who were not acquired informed consent
- •The patients who had technically difficult structure for ERCP
研究组 & 干预措施
uncovered double bare metallic stent (S&G Biotech.)
Active Comparator
uncovered double bare metallic stent
干预措施: metallic biliary stent insertion (double bare - S&G Biotech.) (Procedure)
uncovered single bare metallic stent (S&G Biotech.)
Active Comparator
uncovered single bare metallic stent
干预措施: metallic biliary stent insertion (single bare - S&G Biotech.) (Procedure)
uncovered single bare metallic stent (Taewoong Medical.)
Active Comparator
uncovered single bare metallic stent
干预措施: metallic biliary stent insertion (single bare - Taewoong Medical.) (Procedure)
结局指标
主要结局
Median patency duration
时间窗: Approximately 6 months later since the date of stent insertion
Primary end point : A. Median patency duration
次要结局
- 6-months patency rate(Approximately 6 months later since the date of stent insertion)
研究者
研究点 (2)
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