Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Local tumor response
研究概览
简要总结
The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma (HCC) in patients of cirrhosis of liver.
详细描述
Setting The study would be conducted at the All India Institute of Medical Sciences, New Delhi, a tertiary care teaching hospital, in the departments of Gastroenetrology and Radiodiagnosis.
Sample size Taking RFA as a standard procedure with an estimated success rate of 95%, a sample size of minimum 27 for each arm is required to detect an equivalence difference of 10%, assuming that PAI has a success rate of 85%. This sample size is expected to provide a power of 80%.
Randomization
- Stratified randomization of Child A and B will be done.
- Randomization into A (Acetic acid) and B (Radiofrequency ablation) will be done.
Diagnostic criteria
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child's A or B cirrhosis with liver mass.
- •Number of liver masses not more than 5 and the size of each <5cm in diameter.
- •No extrahepatic disease.
- •Absence of malignant portal vein thrombosis.
- •Platelet count more than 70,000/mm3
- •Prothrombin time more than 50%.
- •Written consent of patient.
排除标准
- •Childs'C cirrhosis with liver mass.
- •Liver mass >5cm in diameter.
- •Number of liver masses more than 3
- •Peripherally located masses with no hepatic parenchyma around
- •Liver mass not discernable on ultrasound.
- •Extra hepatic disease like RP adenopathy, distant metastasis.
- •Coagulation disorders.
- •Unwilling patient
结局指标
主要结局
Local tumor response
时间窗: 2 years
次要结局
- Survival rate(2 years)
- Number of patients with complications(2 years)
- Change from baseline in Child status at 1 year(2 years)
研究者
Subrat Kumar Acharya
Proffessor and Head
All India Institute of Medical Sciences, New Delhi