Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
研究概览
简要总结
The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.
详细描述
Prospective cohort study
Survival
- Overall survival rate
- Disease free survival rate
Recurrence
- Cumulative recurrence rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child-Pugh Class A or B
- •Maximal tumor size less than 5 cm
- •No previous history of treatment for hepatocellular carcinoma
- •Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap
排除标准
- •Hepatocellular carcinoma in portal vein
- •Hepatocellular carcinoma in hepatic vein
研究组 & 干预措施
radiofrequency thermal ablation
Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)
干预措施: RFTA (Procedure)
percutaneous ethanol injection therapy
Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)
干预措施: PEIT (Procedure)
结局指标
主要结局
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
时间窗: 1,3,5 year
The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.
次要结局
- Overall Survival(through study completion, an average of 3 years)
研究者
Jung-Hwan Yoon
Professor
Seoul National University Hospital