The Effect of Ischemia/Reperfusion Injuries Elicited by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Excision:A Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients.
详细描述
Until now there are two popular procedures during the radical excision of primary liver cancer in our country.One is to give a pringle manoeuvre to control the operative blood loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while without liver ischemia.According to the recent experimental studies in rats,we know that the ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to test the actual contribution of ischemia on human,we conduct this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of resectable primary liver cancer
- •The liver function showed:Child-Pugh A，ICG-R15 < 20%
- •HbsAg (+)
- •tumor nodes in the liver were singular or multiple and could be radical excision
- •No preoperative anti-cancer therapy
- •Written informed consent from the patient or legal guardian prior to entering the study
排除标准
- •Pregnancy patients
- •With extrahepatic tumor or lymphnode metastasis
- •Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
- •Positive marginal
结局指标
主要结局
Disease free survival
时间窗: 1,3,5-year
次要结局
- overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc(baseline~2 weeks, 5-year overall survival)
研究者
feng xiaobin
Dr Feng xiaobin
Southwest Hospital, China