Anatomical Radiofrequency Ablation for Peripherally Located Small Hepatocellular Carcinoma Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.
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
- •Presence of chronic hepatitis B or liver cirrhosis.
- •Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
- •Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
- •Tumor location is less than 5 cm from liver capsule.
排除标准
- •The number of tumor is three or more.
- •Tumor size is over 3 cm.
- •Tumor location is over 5 cm from liver capsule.
- •Child-Pugh class B8-9 or C.
- •Presence of macrovascular invasion and/or distant metastasis.
- •Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin time >1.5 × normal).
研究组 & 干预措施
Patients with hepatocellular carcinoma (equal or less than 3 cm)
Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode.
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
Technical success
时间窗: Immediately after radiofrequency ablation
Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Local tumor progression rate
时间窗: 12 months after radiofrequency ablation
Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success.
次要结局
- Complication after radiofrequency ablation(Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation)
- Recurrence-free survival(12 months after radiofrequency ablation)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital