NCT00280709已完成4 期
Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.
University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
研究概览
简要总结
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or older
- •oral and written information given and informed consent obtained
- •clinical data in accordance with malignant bile duct obstruction
- •ultrasonography signs of extrahepatic malignant common bile duct obstruction
- •typical radiological findings at ERCP of malignant common bile duct stenosis
- •proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence
- •bilirubin > 50 micromol/L
- •radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent)
排除标准
- •patients with active hepatitis or other hepatic diseases that may cause jaundice
- •informed consent not obtained
- •metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria)
- •the patient is probably a candidate for surgical resection
- •suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
- •the proximal end of the stenosis is located within 2 cm from the hepatic confluence
- •the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult
- •previously (more than 4 weeks earlier) treated with a bile duct stent
- •severe coagulation disturbance (PK-INR > 1.6)
结局指标
主要结局
Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
时间窗: 12 months after stent insertion
次要结局
未报告次要终点
研究者
研究点 (2)
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