NCT01063634Unknown不适用
Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial
Kliniken Ludwigsburg-Bietigheim gGmbH1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 1
研究概览
简要总结
This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •histologically proven malignant biliary stenosis
- •signs of biliary obstruction
- •informed consent
排除标准
- •age under 18
- •Operations like Roux-Y, biliodigestive Anastomosis, BII
- •life expectancy less than 3 months
- •Karnfosky index less than 60%
研究者
研究点 (1)
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