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Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment
This study is currently recruiting participants.
Study NCT00827047   Information provided by Eastern Hepatobiliary Surgery Hospital
First Received: January 21, 2009   No Changes Posted
This Tabular View shows the required WHO registration data elements as marked by

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
 
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.

 
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
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Both
18 Years to 75 Years
No
Contact: chengjun Sui, M.D 0086-21-25075395 suichengjun1978@hotmail.com
Contact: jiamei Yang, M.D 0086-21-25070808 jiameiyang@gmail.com
China
 
 
NCT00827047
Jiamei Yang, The Department of Special Treatment , Eastern Hepatobiliary Surgery Hospital
 
Eastern Hepatobiliary Surgery Hospital
 
Study Chair: Feng Shen, M.D Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Eastern Hepatobiliary Surgery Hospital
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.