NCT02832882已完成不适用
Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- 12 month local tumor progression (LTP) rate
研究概览
简要总结
In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child-Pugh class A
- •patient with 1cm-2.5cm sized HCC
- •1 or 2 HCCs
- •being referred for curative purpose of RFA
- •sign informed consent
排除标准
- •maximum tumor diameter greater than 2.5cm
- •Child-Pugh class B or C
- •more than 3 HCC lesions
- •invisible tumor even after US/CT or US/MR fusion
- •presence of vascular tumor thrombosis or extrahepatic metastasis
- •severe coagulopathy (PLT < 50K, PT < 50% of normal range)
结局指标
主要结局
12 month local tumor progression (LTP) rate
时间窗: 12 month after RFA
次要结局
- tumor seeding rate(12 months after RFA)
- Complication rate related with RFA(1 month)
- Technical success rate(1 months)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
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