Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Local tumor progression rate
研究概览
简要总结
To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.
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 or B
- •chronic hepatitis B or liver cirrhosis
- •contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
- •clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm
排除标准
- •number of HCC, equal or more than 3
- •largest tumor size over 4 cm
- •Child-Pugh class C
- •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
研究组 & 干预措施
Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )
Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).
干预措施: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes (Procedure)
结局指标
主要结局
Local tumor progression rate
时间窗: 12 months after radiofrequency ablation (RFA)
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
次要结局
- Success rate of cone-unit ablation(Immediately after radiofrequency ablation (RFA))
研究者
Jeong Min Lee
Professor
Seoul National University Hospital