Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Tumor response
研究概览
简要总结
The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of small hepatocellular carcinoma in patients with cirrhosis.
详细描述
Percutaneous ablation is a safe and effective therapy for cirrhotic patients with HCC when resection or liver transplantation is not possible. Among the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for single HCC ≤ 5.0cm or ≤3 HCC nodules ≤3cm. Some studies have shown that laser ablation (LA) may be as effective as RFA in the treatment of HCC. However, RFA and LA are different techniques and, in different cases (for example: size or site of HCC nodule), each of these procedures may have some advantages or disadvantages. Therefore there is the need for a prospective randomized controlled study to compare RFA and LA in patients with small HCC.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable HCC or who refused surgery
- •A solitary HCC ≤ 5.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
- •Child-Pugh class A or B
- •Platelet count correctable to > 40,000/mm3, INR correctable to < 2.0
- •No previous treatment of HCC
排除标准
- •Other severe concomitant diseases that may reduce life expectancy
- •History of encephalopathy, refractory ascites or variceal bleeding
- •Vascular invasion or extrahepatic metastasis
- •Human immunodeficiency virus (HIV) infection
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
结局指标
主要结局
Tumor response
时间窗: four weeks after treatment
Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging
次要结局
- time to local recurrence(12 months after treatment)
- overall survival(12 months after last treatment)
研究者
Giovan Giuseppe Di Costanzo
MD
Cardarelli Hospital