A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated in China.The treatment is being from simplification to diversification,from entirety to individualization.Confronting small hepatocellular carcinoma,we not select simple operation treatment but select a treatment that have more predominance and more fitting with patients in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ? There are many arguments.
详细描述
randomly put in group standard:
- via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
- age: 18-70 years.
- early hepatocyte cancer，which is single focus of infection diameter ≤ 3 cm.
- estimate tumor can gain treatment of curing operation or TACE plus PEI.
- better liver function (Child-Pugh，class A or B).
Case loads: 160 residents with small hepatocellular carcinoma in China
Therapeutic regimen: under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.
Research end-point:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
- •age:18-70years
- •early hepatocyte cancer，which is single focus of infection diameter ≤3cm.
- •estimate tumor can gain treatment of curing operation or micro-create treatment combineation
- •better liver function (Child-Pugh，class A or B)
排除标准
- •reject to attend；
- •impossible to come to our hospital for physical examination regularly.
- •cancer epitome、seed focus、lymph node or distant metastasis
- •Blood clotting function hindrance;
- •serious heart、lung、kidney disease.
结局指标
主要结局
overall survival
时间窗: 2010
次要结局
未报告次要终点
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital