Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
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
- LTP
研究概览
简要总结
To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.
详细描述
To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all conditions have to be fulfilled.
- •Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
- •liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
- •signed informed consent
- •treatment naive index tumor (no history of local treatment for an index tumor)
排除标准
- •more than three tumors in a patients
- •tumor size larger than 5cm
- •tumor attaches to central portal vein or hepatic vein
- •Child-Pugh classification C
- •uncorrected coagulopathy
- •presence of extrahepatic metastases
结局指标
主要结局
LTP
时间窗: 24 months
cumulating local tumor progression rate over 2- year after RFA
次要结局
- Technical success rate(1 months)
- EM rate(24 months)
- Complication(12 months)
- Maximal diameter of ablative zone(7 day)
- Volume of ablative zone(7 days)
- IDR rate(24 months)
- ablation time(1 day)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital