Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Patency
研究概览
简要总结
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.
详细描述
This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable malignancy of the extrahepatic bile duct
排除标准
- •Age below 21 years
- •Pregnancy
- •Active alcohol or drug abuse
- •Simultaneously participating in another investigational drug or device study.
- •Allergy to stainless steel or nitinol
- •Active cholangitis
- •Brachytherapy
- •Unable or unwilling to comply with follow up
结局指标
主要结局
Patency
时间窗: up to 32 months
Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\>= 6 months after placement).
Closure or Blockage of the Stent (Occlusion)
时间窗: up to 32 months
Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
Number of Days to Occlusion
时间窗: up to 32 months
Number of Deaths
时间窗: up to 32 months
Time to Death
时间窗: up to 32 months
Overall Survival
次要结局
未报告次要终点