Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Complete ablation rate
研究概览
简要总结
The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).
The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.
A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation
- •Resectable HCC but patient opts for local ablation
- •Maximum diameter of tumor ≤6cm
- •Maximum number of tumor nodules ≤3
- •Absence of radiology evidence of major vascular or bile duct invasion
- •Child's A or B liver function
- •Karnofsky performance status ≥70%
排除标准
- •Informed consent not available
- •Pregnant female patients
- •Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis)
- •HCC with history of rupture
- •Concomitant hepatectomy
- •Patients with chronic renal failure
研究组 & 干预措施
Microwave
Hepatocellular carcinoma treated with microwave ablation
干预措施: Microwave ablation (Procedure)
Radiofrequency
Hepatocellular carcinoma treated with radiofrequency ablation
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
Complete ablation rate
时间窗: 1 month
Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)
次要结局
- Treatment related mortality(30-day)
- Long-term liver function(3 year)
- Recurrent disease(3 year)
- Survival(3 year)
- Treatment related morbidity(30-day)
- Hospital stay(30-day)
研究者
Cheung Yue Sun
Associate Consultant
Chinese University of Hong Kong