Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Tumor size assessed by MRI
研究概览
简要总结
To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation for liver tumors, the investigators used preoperative and postoperative US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥ 50*10e9/L and PT(prothrombin time) ≤ 20s.
排除标准
- •Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.
研究组 & 干预措施
RFA(radiofrequency ablation)
The investigators used percutaneously US-guided RFA(radiofrequency ablation) for small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.
干预措施: US-guided RFA (Procedure)
结局指标
主要结局
Tumor size assessed by MRI
时间窗: through study completion, an average of 2 year
Tumor size was estimated by MRI.
次要结局
- Carcinoembryonic Antigen (CEA) level assessed by ELISA(through study completion, an average of 2 year)
- Alpha Fetoprotein (AFP) level assessed by ELISA(through study completion, an average of 2 year)