Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus MP Electrodes or Octopus Electrodes With Adjustable Tips: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Adjacent organ thermal injury rate
研究概览
简要总结
This study is to investigate the therapeutic effect and treatment results of radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring and drug injection and a variable-length electrode for treatment of small hepatocellular carcinomas (≤ 3cm).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or B
- •chronic hepatitis B or chronic hepatitis C or liver cirrhosis
- •presence of hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines.
- •up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment.
排除标准
- •number of recurrent HCCs, more than 3
- •largest HCC size over 3 cm
- •presence of vascular invasion by HCC
- •platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
- •presence of extrahepatic metastasis
结局指标
主要结局
Adjacent organ thermal injury rate
时间窗: Immediately after radiofrequency ablation
Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation.
Local tumor progression rates
时间窗: 1 and 2 years after radiofrequency ablation
local tumor progression (LTP) rates , defined as new tumor foci at the ablation margin after initial complete ablation, as confirmed by a consensus of two radiologists on follow-up imaging
次要结局
未报告次要终点
研究者
Jeong Min Lee
Professor
Seoul National University Hospital