NCT03806218已完成不适用
Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Minimum diameter of ablation zone per unit time
研究概览
简要总结
This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
- •HCC nodules measuring 1 cm or larger and smaller than 5 cm
排除标准
- •more than three HCC nodules
- •tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter > 5mm
- •extrahepatic metastasis
- •Child-Pugh class C
- •severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)
结局指标
主要结局
Minimum diameter of ablation zone per unit time
时间窗: 3 days after RFA
Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.
次要结局
- Technique efficacy(1 month after RFA)
- IDR rate(12 months, 24 months after RFA)
- EM rate(12 months, 24 months after RFA)
- Local tumor progression (LTP)(12 months, 24 months after RFA)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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