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Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy (SHVE)
This study is currently recruiting participants.
Verified by Eastern Hepatobiliary Surgery Hospital, January 2009
First Received: January 9, 2009   No Changes Posted
Sponsored by: Eastern Hepatobiliary Surgery Hospital
Information provided by: Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00820339
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Procedure: Selective Hepatic Vascular Exclusion
Procedure: Pringle's Maneuver
Phase II
Phase III

MedlinePlus related topics: Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 132
Study Start Date: January 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Selective Hepatic Vascular Exclusion: Active Comparator
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.
Pringle's Maneuver: Experimental
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820339

Contacts
Contact: Weiping Zhou, M.D. 0086-21-25070792 ehphwp@126.com
Contact: Siyuan Fu, M.D. 0086-21-25070772 fusiyuan1993@yahoo.com.cn

Locations
China
Eastern hepatobilliary surgery hospital Recruiting
Shanghai, China
Contact: Weiping Zhou, M.D.     0086-021-25070792     ehphwp@126.com    
Contact: Siyuan Fu, M.D.     0086-021-25070772     fusiyuan1993@yahoo.com.cn    
Principal Investigator: Weiping Zhou, M.D.            
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Feng Shen, M.D. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

No publications provided

Responsible Party: The Third Department of Hepatic Surgery,Eastern Hepatobiliary Surgery Hospital ( Weiping Zhou )
Study ID Numbers: EHBH-RCT-2008-002
Study First Received: January 9, 2009
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00820339     History of Changes
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
hepatic vein
Surgical resection
occlusion
time to recurrence
overall survival

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009