NCT02102984已完成不适用
Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Relief of malignant biliary obstruction
研究概览
简要总结
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
详细描述
Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
- •not eligible for surgical intervention
- •able to provide informed consent
排除标准
- •benign biliary obstruction
- •previous surgery of the biliary tract
- •life expectancy < 3 months
结局指标
主要结局
Relief of malignant biliary obstruction
时间窗: six months
Clinical assessment
次要结局
- cost/effecacy(6 months)
研究者
Rita Conigliaro, MD
Chief - Endoscopy Unit
Nuovo Ospedale Civile S.Agostino Estense
研究点 (2)
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