NCT00357422已完成不适用
Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- overall survival rate
研究概览
简要总结
The purpose of this study is to choose the preferred treatment modality for solitary, small hepatocellular carcinoma.
详细描述
To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group:
- Survival
- 5 year overall survival rate
- Disease free survival rate
- Recurrence
- Cumulative recurrence rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The evidences of hepatitis B virus (HBV)&/or hepatitis C virus (HCV) infection or liver cirrhosis
- •Single tumor nodule with Child-Pugh classification A (serum albumin ≥ 3.2 g/dL)
- •The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm
- •Only for the newly detected HCCs which were not treated before
- •It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI)
- •Without portal hypertension
排除标准
- •In case of hepatic vein or portal vein invasion radiologically (CT or MRI)
研究组 & 干预措施
surgery
Active Comparator
干预措施: Operation (Procedure)
local therapy
Active Comparator
干预措施: Percutaneous ethanol injection therapy (Procedure)
结局指标
主要结局
overall survival rate
时间窗: 5 year
次要结局
- disease free survival rate and recurrence rate(5 year)
研究者
Jung-Hwan Yoon
Professor
Seoul National University Hospital
研究点 (1)
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