A Randomized Controlled Trial of Microwave and Radiofrequency Ablation in the Treatment of Early-stage Hepatocellular Carcinoma Meeting Milan Criteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
研究概览
简要总结
According to randomized controlled trial requirement, the therapeutic effectiveness of cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular carcinoma is compared to find a better approach for minimally invasive thermal ablation.
详细描述
According to following enrollment standard, about >400 cases of biopsy-proved hepatocellular carcinoma(HCC) patients will be involved in the study. They will be treated with percutaneously microwave ablation (MWA) and radiofrequency ablation(RFA). The indications of patients enrolled in the study were as follows: tumor size ≤5cm in diameter, tumor number ≤3, Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumor embolus, and no any other anti-cancer treatment was accepted. MWA or RFA is selected for the patient according to the sequence of their visit to the hospital based on randomization number arrangement produced by SPSS 16.0 statistical software. The therapeutic effectiveness will be compared between two modalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •tumor size ≤5cm in diameter,
- •tumor number ≤3,
- •Child-Pugh class A or B classification,
- •no evidence of extrahepatic metastasis,
- •vein or bile duct tumor embolus, and
- •no any other anti-cancer treatment
排除标准
- •not meeting the inclusion criteria
研究组 & 干预措施
microwave ablation
microwave ablation
干预措施: microwave ablation (Device)
radiofrequency ablation
radiofrequency ablation
干预措施: radiofrequency ablation (Device)
结局指标
主要结局
Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
时间窗: up to 79 months
次要结局
- An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.(up to 79 months)
- disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.(up to 79 months)
- Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.(up to 79 months)
- Wilcoxon test was used for comparing liver function between MWA and RFA.(up to 79 months)
研究者
Ping Liang
Chair
Chinese PLA General Hospital