Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Biliary stent patency
研究概览
简要总结
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.
详细描述
Study design: randomized single-blind control trial Study population: patient with unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival Intervention
- Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped
- All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent.
- Monitor for adverse event during hospitalization and during follow up
- Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hilar cholangiocarcinoma diagnosed by imaging or pathology
- •Considered unresectable or unfit for surgery
- •Presence of obstructive jaundice need endoscopic biliary drainage
排除标准
- •History of unremovable metallic biliary stent placement
- •severe biliary stricture that the instrument was unable to pass through
- •unfit for endoscopic under conscious sedation
- •loss to follow up and loss contact within 6 months after intervention
结局指标
主要结局
Biliary stent patency
时间窗: up to 6 months
The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure
次要结局
- Patient survival(up to 6 months)