NCT00945516已完成3 期
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Stent migration rate
研究概览
简要总结
The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.
详细描述
Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Patient with benign bile duct stricture
排除标准
- •No written informed consent
- •Malignant biliary obstruction
- •Patients with uncorrectable severe coagulopathy
- •Patients with severe cardiopulmonary disease precluding sedation
结局指标
主要结局
Stent migration rate
时间窗: one year
次要结局
- Feasibility (Technical success rate and functional success rate)(one year)
- Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)(one year)
- Removability(one year)
研究者
研究点 (2)
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