A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the overall survival rate of each group
研究概览
简要总结
The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.
详细描述
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad, still shows a rising trend. Postoperative hepatic failure remains a major reason of liver resection's failure.
• As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can improve survival in HCC patients or not.
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
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 35 years and <=55 years of age.
- •confirmed case (patients with HCC)
- •Tumors can be radical removed and resection volume was 50% to 70%.
- •Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- •No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
- •Karnofsky Performance Score performance over
- •Patients who can understand this trial and have signed information consent.
排除标准
- •Patients who have undergone previous treatment by Ulinastatin.
- •Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
- •Patients with other diseases which may affect the treatment mentioned here.
- •Patients with medical history of other malignant tumors.
- •Subjects participating in other clinical trials.
- •Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
- •Patients would not sign the consent to the trial.
研究组 & 干预措施
Diammonium glycyrrhizinate
Conventional drugs protect liver
干预措施: Diammonium glycyrrhizinate (Drug)
Ulinastatin
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
干预措施: Ulinastatin (Drug)
结局指标
主要结局
the overall survival rate of each group
时间窗: 3 years
次要结局
未报告次要终点
研究者
ShenFeng
director of department of special treatment
Eastern Hepatobiliary Surgery Hospital