Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)
研究概览
简要总结
The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.
详细描述
Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.
Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction.
The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant hilar biliary obstruction;
- •Unresectable cases
排除标准
- •Bismuth I patients;
- •inability to obtain informed consent;
- •Eastern Cooperative Oncology Group performance status of 4;
- •severe dysfunction in other organs.
研究组 & 干预措施
Unilateral stent
Patients undergo placement of unilateral biliary stent on day 1.
干预措施: biliary stent (Device)
Bilateral stents
Patients undergo placement of bilateral biliary stents on day 1.
干预措施: biliary stent (Device)
结局指标
主要结局
Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)
时间窗: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
Stent dysfunction is suspected when the patient experiences recurrence of jaundice.
次要结局
- Overall survival(From the date of randomization until the date of first documented death from any cause, assessed up to 12 months)
- Stent dysfunction free-patient survival(From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 10 months.)