Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)
研究概览
简要总结
The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.
详细描述
There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (~3-9 months).
Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)
排除标准
- •Patients with ASA 4 or 5
- •Patients with liver failure.
- •Patients unable to comply with follow-up
结局指标
主要结局
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)
时间窗: at 2 weeks and 4 weeks after stent insertion
Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)
时间窗: at 2 weeks and 4 weeks after stent insertion
Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.
次要结局
- Cost Effective Ratio of Metallic and Plastic Stent(until the patients expire (Markov model))
- Patients Survival Times(until patient died or 6 months after the last patient was enrolled)
研究者
Apichat Sangchan
Assist. Prof.
Khon Kaen University