Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study
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
- 否
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
Tae Hoon Lee
Professor
Soon Chun Hyang University
