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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
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Selective Hepatic Vascular Exclusion Procedure: Pringle's Maneuver Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1,2,or 3 years ]

Secondary Outcome Measures :
  1. Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications [ Time Frame: 1,2,or 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
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Study Chair: Feng Shen, M.D. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
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Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00820339    
Other Study ID Numbers: EHBH-RCT-2008-002
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
hepatic vein
Surgical resection
occlusion
time to recurrence
overall survival
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases