NCT05449860Unknown不适用
Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Local tumor progression rate
研究概览
简要总结
To investigate the therapeutic effects and treatment results of radiofrequency ablation using combined bipolar and monopolar energy deliver with twin cooled-wet electrodes for recurrent tumor after locoregional treatment 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 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
- Safety margin evaluation(Immediately after radiofrequency ablation)
- Technical success rate(1 month after radiofrequency ablation)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP ElectrodesHepatocellular CarcinomaNCT05666271Seoul National University Hospital76
Unknown
不适用
RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet ElectrodesRadiofrequency AblationCarcinoma, HepatocellularNCT04331184Seoul National University Hospital102
撤回
2 期
Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)Carcinoma, HepatocellularNCT01669668Washington University School of Medicine
已完成
3 期
Hepatocellular Carcinoma Treated With Iodine-125 ImplantationLiver CarcinomaNCT01717729The Second People's Hospital of GuangDong Province136
Unknown
4 期
Trial of Ablation of Small Hepatocellular Carcinomas in Patients of CirrhosisHepatocellular CarcinomaNCT01438437All India Institute of Medical Sciences, New Delhi54