NCT01457105已完成不适用
PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures
研究概览
简要总结
self-expandable metal stents for palliation of malignant biliary strictures
详细描述
The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.
Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.
- •Patients without liver metastases and 6 months life expectancy
- •Patients at the first attempt of endoscopic biliary drainage.
- •Negative history for biliary tract surgery.
排除标准
- •Patients with ampullary cancer.
- •Patients with hilar and/or intra-hepatic ducts malignancy.
- •Patients with haemobilia.
- •Patients with acute cholangitis at the time of stenting.
- •Patients with previous percutaneous, endoscopic or surgical biliary drainage.
结局指标
主要结局
patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures
时间窗: two years
次要结局
未报告次要终点
研究者
Professor Guido Costamagna
Professor
Catholic University of the Sacred Heart
研究点 (2)
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