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

Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

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

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

1,2,or 3 years

Safety Issue:


Principal Investigator

Feng Shen, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University


China: Ministry of Health

Study ID:




Start Date:

January 2009

Completion Date:

November 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • hepatic vein
  • Surgical resection
  • occlusion
  • time to recurrence
  • overall survival
  • Carcinoma
  • Carcinoma, Hepatocellular