Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 12 month local tumor progression (LTP) rate
研究概览
简要总结
The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.
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 1-2.5cm sized HCC
- •1 or 2 HCC lesions
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)
研究组 & 干预措施
No-touch RFA arm
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
干预措施: No-touch RFA arm (Procedure)
Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.
干预措施: Conventional tumor puncture RFA arm (Procedure)
结局指标
主要结局
12 month local tumor progression (LTP) rate
时间窗: 12 months after RFA
次要结局
- 2. tumor seeding rate(12 months after RFA)
- Complication rate related with RFA(1 month after RFA)
- Technical success rate(1 month after RFA)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital