Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Local treatment responses
研究概览
简要总结
The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA) in the treatment of early-stage hepatocellular carcinoma (HCC).
详细描述
Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more than 3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol ablation. The local treatment responses, complications,and long-term disease-free survivals and overall survivals are analyzed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hepatocellular carcinoma, single tumor ≤5 cm or up to 3 tumors each ≤3 cm
- •Ultrasound detectable tumor
- •Liver function classified as Child-Pugh A or B
- •Platelet count > 50,000/mm3, or prothrombin activity > 50%
- •Not suitable for resection or patient refused surgery
排除标准
- •Vascular invasion and extrahepatic spread
- •Patients allergic to ethanol
研究组 & 干预措施
QFEA
multi-pronged ethanol ablation
干预措施: multi-pronged ethanol ablation (Procedure)
RFA
radiofrequency ablation
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
Local treatment responses
时间窗: 2 years
次要结局
- Disease-free survivals and overall survivals(3 years)
研究者
Ming-de Lu
Department of Medical Ultrasound
Sun Yat-sen University