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Clinical Trials/NCT00827047
NCT00827047CompletedNot Applicable

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

Eastern Hepatobiliary Surgery Hospital1 site in 1 country150 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
Overall survival and disease free survival

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Overall survival and disease free survival

Time Frame: 1,2,or 3 years

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Eastern Hepatobiliary Surgery Hospital

Study Sites (1)

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