NCT01041612已完成4 期
Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study
Taewoong Medical Co., Ltd.18 个研究点 分布在 3 个国家目标入组 120 人开始时间: 2010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
- 120
- 试验地点
- 18
- 主要终点
- Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange
研究概览
简要总结
The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old
- •Bile duct or gallbladder cancer invading CBD or distal CHD
- •Pancreatic cancer with mid or distal CBD invasion
- •Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
- •First attempt of endoscopic biliary metallic stenting
- •Negative history of biliary tract surgery
- •Life expectancy at least longer than 4 months (Karnofsky score >60%)
排除标准
- •Ampullary cancer
- •Klatskin tumor
- •Combined intrahepatic bile duct cancer
- •Patient with hemobilia
- •Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days
结局指标
主要结局
Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange
时间窗: one year
次要结局
- Death of patients(one year)
研究者
Jong Taek, Lee
General manager
Taewoong Medical Co., Ltd.
研究点 (18)
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