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临床试验/NCT00827047
NCT00827047已完成不适用

A Prospective Randomized Controlled Trial of Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年1月1日最近更新:
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
150
试验地点
1
主要终点
Overall survival and disease free survival

研究概览

简要总结

Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.This study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with hemihepatic vascular clamping and Pringle maneuver.

详细描述

The amount of blood loss and blood transfusion in Hepatectomy have a detrimental effect on the prognosis for Hepatocellular carcinoma(HCC).Intraoperative bleeding remains a major concern during liver resection. The most often used hepatic vascular control methods at present are hepatic pedicle occlusion(Pringle maneuver), hemihepatic vascular clamping,segmental vascular clamping and total hepatic vascular exclusion (THVE).However,all these methods have shortcomings. Pringle maneuver cannot prevent bleeding from hepatic veins and leads to ischemia-reperfusion injury of the liver; Hemihepatic vascular clamping cannot prevent bleeding from hepatic veins as well, and from the remnant (nonoccluded) liver. THVE is a technically demanding technique that requires surgical and anesthetic expertise and may lead to hemodynamic intolerance as well as increased morbidity and hospital stay. Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.

The purpose of this study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with other occlusion methods.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •5Inclusion Criteria:
  • •Understanding and being willing to sigh the informed consent form.
  • •Aged 18-75years.
  • •Corresponding to diagnostic standards of HCC, without any adjuvant therapy,tumor or multiple tumors located in right or left liver lobe.
  • •The function of heart, lung ,renal is well,without any surgery contraindication.
  • •KPS score≥60 分
  • •Liver function in the Child-Pugh classification is A or B.
  • •Tumor AJCC stage isⅠorⅡ.

排除标准

  • •cannot be follow-up
  • •liver function in the Child-Pugh classification is C.
  • •with tumor thrombus in the hepatic vein or main trunk of portal vein
  • •with extrahepatic metastasis

研究组 & 干预措施

Total Hemihepatic Vascular Exclusion

Active Comparator

Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.

干预措施: Total hemihepatic vascular exclusion (Procedure)

Hemihepatic vascular Clamping

Experimental

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.

干预措施: Hemihepatic vascular Clamping (Procedure)

Pringle's Maneuver

Experimental

Patients with HCC received Pringle's Maneuver in hepatectomy.

干预措施: Pringle's Maneuver (Procedure)

结局指标

主要结局

Overall survival and disease free survival

时间窗: 1,2,or 3 years

次要结局

  • Bleeding and 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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