NCT01739465Unknown2 期
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
Guangzhou Medical University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- stent patency
研究概览
简要总结
The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Pathologically or radiologically confirmed biliary malignant
- •Inoperability by staging
排除标准
- •Cholangiocarcinoma with widespread metastasis
- •Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
- •Prior SEMS placement
- •Pregnancy
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
- •Life expectancy < 3months
结局指标
主要结局
stent patency
时间窗: 6 months
次要结局
- overall survival rate(3 years)
研究者
Huihong Liang
Associated Professor
Guangzhou Medical University
研究点 (2)
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