Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Stent patency
研究概览
简要总结
The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months.
There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.
The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar 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
- None
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
- •Patient over 18 years old
- •Patient with malignant hilar obstruction
排除标准
- •No written informed consent
- •Patient with uncorrectable severe coagulopathy
- •Indication for surgical operation
- •Karnofsky score < 60%
结局指标
主要结局
Stent patency
时间窗: Up to 2 years
Interval time (d) from stent insertion to occlusion
次要结局
- All cause complications(Up to 2 years)
- Cost-effectiveness(Up to 2 years)
- Mortality(Up to 2 years)
- Technical success(within 24 hr after stent insertion)