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Completed

NCT Number: NCT00820339

Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selective hepatic vascular exclusion

Procedure

Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.

Other names: SHVE group

Pringle's Maneuver

Procedure

Hepatic pedical clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.

Other names: Pringle's Maneuver group

Primary outcomes

  1. Overall survival

    Time frame: 1,2,or 3 years

Secondary outcomes

  1. Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications

    Time frame: 1,2,or 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

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

Acronym: SHVE

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 12, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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