跳至主要内容
临床试验/NCT02659852
NCT02659852Unknown不适用

A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Yonsei University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Median patency duration

研究概览

简要总结

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.

The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.

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

  • •Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
  • •older than 20 years old

排除标准

  • •Operable case
  • •Non-hilar biliary malignant obstruction
  • •Duodenal obstruction
  • •Other cancer except biliary malignancy
  • •uncontrolled infection status
  • •Eastern Cooperative Oncology Group ≥ 3
  • •No signed informed consent
  • •Failed endoscopic approach to duodenum or biliary tract

研究组 & 干预措施

Side by side group

Experimental

干预措施: side by side (Procedure)

Stent in stent group

Active Comparator

干预措施: stent in stent (Procedure)

结局指标

主要结局

Median patency duration

时间窗: 1 year after stent insertion

Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent

次要结局

  • Overall survival(1 year)
  • complication rate(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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