NCT03375281已完成不适用
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 7
- 主要终点
- 1 year local tumor progression
研究概览
简要总结
The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 liver function
- •1 - 2.5 cm sized Single nodular HCC
- •without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment
排除标准
- •more than 2 HCC
- •tumor size larger than 2.5 cm
- •Child-Pugh class B or C liver function
- •invisible tumor even after real-time fusion US guidance
- •accompanied by vascular invasion or distant metastasis
- •presence of coagulopathy defined as platelet count < 50,000/mm3 and/or PT-INR > 50%
结局指标
主要结局
1 year local tumor progression
时间窗: 1 year after procedure
cumulative incidence of local tumor progression after RFA
次要结局
未报告次要终点
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (7)
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