Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Duration of stent patency
研究概览
简要总结
The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.
详细描述
In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure
排除标准
- •If endoscopy is not possible based on the judgement of the researcher
- •Life expectancy less than 6 months
- •Acute cholecystitis
- •Previous history of percutaneous transhepatic biliary drainage
- •Previous history of metal stent placement for malignant biliary stricture
研究组 & 干预措施
FCSEMS
In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography.
干预措施: endoscopic retrograde cholangio-pancreatography (Procedure)
Plastic stent
In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture.
干预措施: endoscopic retrograde cholangio-pancreatography (Procedure)
结局指标
主要结局
Duration of stent patency
时间窗: 9 months after randomization.
The period from the insertion of the stent to the point at which stent revision is required.
次要结局
未报告次要终点