NCT06682377进行中（未招募）不适用
Evaluation of Clinical Efficacy of Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma: a Prospective Multicenter Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Estimated local tumor progression rate
研究概览
简要总结
The purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "No-touch" technique. This approach employs Octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of 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
- •**Inclusion Criteria**
- •Agreement to the protocol requirements and provision of informed consent.
- •Age between 20 and 85 years.
- •Child-Pugh Class A or B
- •Patients with liver cirrhosis who are candidates for radiofrequency ablation (RFA) based on multi-detector computed tomography (MDCT) or multi-detector computed tomography (MRI) within 60 days, with a suspected hepatocellular carcinoma (HCC) lesion of 1-3 cm.
- •**HCC Diagnostic Criteria:** A. Presence of risk factors (e.g., hepatitis B virus (HBV) positive, hepatitis C virus (HCV) positive, liver cirrhosis).
- •B. Findings consistent with HCC on at least one imaging modality (MDCT, dynamic MRI, or Primovist MRI) according to the Korean Liver Cancer Association (KLCA) criteria.
- •C. Histological diagnosis of HCC.
- •No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.
排除标准
- •Presence of three or more malignant liver tumors.
- •Diffuse infiltrative type tumors with unclear boundaries.
- •Recurrent HCC within two years of previous treatment.
- •Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
- •Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
- •Vascular invasion by malignant liver tumors.
- •Severe coagulopathy (platelets <50,000/mm³ or International Normalized Ratio (INR) >50% prolongation).
- •Presence of extrahepatic metastasis.
- •Situations where obtaining appropriate data for the study is unlikely.
研究组 & 干预措施
No touch RFA with dual switching monopolar + bipolar mode
Experimental
干预措施: Radiofrequency ablation alone (Procedure)
结局指标
主要结局
Estimated local tumor progression rate
时间窗: 12 months after procedure
次要结局
未报告次要终点
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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