NCT05449873招募中不适用
No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 73
- 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 no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled 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
- •chronic hepatitis B or chronic hepatitis C or liver cirrhosis
- •presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
- •single lesion less than or equal to 5 cm, or 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, equal or more than 3
- •largest recurrent 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
Local tumor progression rate
时间窗: 12 months after radiofrequency ablation
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
次要结局
- Technical success rate(1 month after radiofrequency ablation)
- Disease-free survival(12 moths after radiofrequency ablation)
- Complication rate(1, 3, 6, 9, 12 months after radiofrequency ablation.)
- Overall survival(12 moths after radiofrequency ablation)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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