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临床试验/NCT00820339
NCT00820339已完成2 期

Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
132
试验地点
1
主要终点
Overall survival

研究概览

简要总结

To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE 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. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying.

Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis.

Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins.

SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.

The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE 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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Corresponding to diagnostic standards of HCC.
  • Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins.
  • liver function in the Child-Pugh classification A or B.
  • Age between 18~70 years.
  • Haven't taken any current treatment.
  • Understanding and being willing to sigh the informed consent form.

排除标准

  • cannot be follow-up
  • severe liver, renal, or brain dysfunction
  • with tumor thrombi in the main trunk of portal vein
  • with tumor thrombi in the hepatic vein
  • with extrahepatic metastasis

结局指标

主要结局

Overall survival

时间窗: 1,2,or 3 years

次要结局

  • Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications(1,2,or 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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