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Sponsored by: |
Eastern Hepatobiliary Surgery Hospital |
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Information provided by: | Eastern Hepatobiliary Surgery Hospital |
ClinicalTrials.gov Identifier: | NCT00820339 |
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 |
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Hepatocellular Carcinoma |
Procedure: Selective Hepatic Vascular Exclusion Procedure: Pringle's Maneuver |
Phase II Phase III |
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 |
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 |
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Selective Hepatic Vascular Exclusion: Active Comparator
Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy.
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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.
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Pringle's Maneuver: Experimental
Patients with HCC received Pringle's Maneuver in hepatectomy.
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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.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Weiping Zhou, M.D. | 0086-21-25070792 | ehphwp@126.com |
Contact: Siyuan Fu, M.D. | 0086-21-25070772 | fusiyuan1993@yahoo.com.cn |
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. |
Study Chair: | Feng Shen, M.D. | Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
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 |
hepatocellular carcinoma hepatic vein Surgical resection |
occlusion time to recurrence overall survival |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Gastrointestinal Neoplasms |
Hepatocellular Carcinoma Adenocarcinoma Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
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 |