January 21, 2009 |
January 21, 2009 |
January 2009 |
Overall survival and disease free survival [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: No ] |
Same as current |
No Changes Posted |
Bleeding and 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 ] |
Same as current |
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Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment |
A Prospective Randomized Controlled Trial of Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment |
Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.This study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with hemihepatic vascular clamping and Pringle maneuver. |
The amount of blood loss and blood transfusion in Hepatectomy have a detrimental effect on the prognosis for Hepatocellular carcinoma(HCC).Intraoperative bleeding remains a major concern during liver resection. The most often used hepatic vascular control methods at present are hepatic pedicle occlusion(Pringle maneuver), hemihepatic vascular clamping,segmental vascular clamping and total hepatic vascular exclusion (THVE).However,all these methods have shortcomings. Pringle maneuver cannot prevent bleeding from hepatic veins and leads to ischemia-reperfusion injury of the liver; Hemihepatic vascular clamping cannot prevent bleeding from hepatic veins as well, and from the remnant (nonoccluded) liver. THVE is a technically demanding technique that requires surgical and anesthetic expertise and may lead to hemodynamic intolerance as well as increased morbidity and hospital stay. Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE. The purpose of this study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with other occlusion methods. |
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Interventional |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Hepatocellular Carcinoma |
- Procedure: Total hemihepatic vascular exclusion
- Procedure: Hemihepatic vascular Clamping
- Procedure: Pringle's Maneuver
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- Active Comparator: Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.
- Experimental: Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.
- Experimental: Patients with HCC received Pringle's Maneuver in hepatectomy.
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Recruiting |
150 |
December 2012 |
December 2010 (final data collection date for primary outcome measure) |
5Inclusion Criteria:
- Understanding and being willing to sigh the informed consent form.
- Aged 18-75years.
- Corresponding to diagnostic standards of HCC, without any adjuvant therapy,tumor or multiple tumors located in right or left liver lobe.
- The function of heart, lung ,renal is well,without any surgery contraindication.
- KPS score≥60分
- Liver function in the Child-Pugh classification is A or B.
- Tumor AJCC stage isⅠorⅡ.
Exclusion Criteria:
- cannot be follow-up
- liver function in the Child-Pugh classification is C.
- with tumor thrombus in the hepatic vein or main trunk of portal vein
- with extrahepatic metastasis
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Both |
18 Years to 75 Years |
No |
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China |
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NCT00827047 |
Jiamei Yang, The Department of Special Treatment , Eastern Hepatobiliary Surgery Hospital |
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Eastern Hepatobiliary Surgery Hospital |
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Study Chair: |
Feng Shen, M.D |
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
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Eastern Hepatobiliary Surgery Hospital |
January 2009 |