Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Major complication rate after Radiofrequency ablation (RFA)
研究概览
简要总结
The purpose of this study is to evaluate the clinical feasibility and short-term outcome of switching monopolar RFA using a separable cluster electrode in patients with primary and secondary liver malignancies.
详细描述
Radiofrequency ablation (RFA) is one of minimal invasive treatment methods and it has been showing comparable overall survival with surgery in early or small hepatocellular carcinomas (HCCs) and better cost-effectiveness. However, it is suffering from high local tumor progression (LTP) rate. To reduce LTP rate, creation of large ablative zone has been attempted in various strategies. A separable cluster electrode is a new type of RFA electrode. It consists of three individual applicators and the applicators can be incorporated as a single handle such as a cluster electrode, and can be separated as three electrodes, depending on operators' needs. It allows high flexibility to operators and the preclinical results were promising. Herein, we want to evaluate the clinical feasibility of the electrodes by observing major complication rates, technical success rate and 12-months LTP rate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatic malignancies diagnosed on biopsy OR
- •Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline
- •Typical imaging feature of metastasis on CT or MRI AND
- •1~5 tumors equal to or smaller than 5cm in the liver
- •no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC)
- •Eastern Cooperative Oncology Group performance status of 0
- •Patients who signed informed consent
排除标准
- •Patients with any of followings are excluded.
- •Patients with uncontrolled coagulopathy
- •Patients with Child-Pugh classification C
- •Patients with tumor invasion in major portal vein or hepatic vein branch
- •Extrahepatic metastasis
研究组 & 干预措施
Separable cluster electrode
radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.
干预措施: Separable cluster electrode (Octopus®) (Device)
结局指标
主要结局
Major complication rate after Radiofrequency ablation (RFA)
时间窗: 30 days after RFA
Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E).
次要结局
- Technical success(1 day after RFA)
- Local control rate(12 months after RFA)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital