NCT01063634
Unknown
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2010年1月
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents
- 发起方
- Kliniken Ludwigsburg-Bietigheim gGmbH
- 入组人数
- 76
- 试验地点
- 1
- 最后更新
- 16年前
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.
研究者
入排标准
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%
结局指标
主要结局
未指定
研究点 (1)
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