Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- local tumor progression (LTP)
研究概览
简要总结
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.
详细描述
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
- •histologically confirmed HCC
- •histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
- •equal to or larger than 2cm, equal to or smaller than 5cm
- •available cross-sectional liver imaging within 30 days before RFA
- •signed informed consent
排除标准
- •history of local treatment on the index tumor
- •more than three tumors in a patient
- •tumors in central portion of portal vein or hepatic vein
- •Child-Pugh class C
- •vascular invasion by tumors
- •uncorrected coagulopathy
- •presence of multiple extrahepatic metastases
结局指标
主要结局
local tumor progression (LTP)
时间窗: 12 months
次要结局
- rate of extrahepatic metastasis (EM) after RFA(12 months)
- Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)(1 months)
- rate of intrahepatic distant recurrence (IDR) after RFA(12 months)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital