Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy (SHVE)
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|ClinicalTrials.gov Identifier: NCT00820339|
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: Selective Hepatic Vascular Exclusion Procedure: Pringle's Maneuver||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||November 2012|
Active Comparator: Selective Hepatic Vascular Exclusion
Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy.
Procedure: Selective Hepatic Vascular Exclusion
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 Name: SHVE group
Experimental: Pringle's Maneuver
Patients with HCC received Pringle's Maneuver in hepatectomy.
Procedure: Pringle's Maneuver
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 Name: Pringle's Maneuver group
- Overall survival [ Time Frame: 1,2,or 3 years ]
- Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications [ Time Frame: 1,2,or 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820339
|Eastern hepatobilliary surgery hospital|
|Shanghai, Shanghai, China|
|Study Chair:||Feng Shen, M.D.||Eastern Hepatobiliary Surgery Hospital, Second Military Medical University|