Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00827047
First received: January 21, 2009
Last updated: March 30, 2016
Last verified: March 2016

January 21, 2009
March 30, 2016
January 2009
December 2010   (final data collection date for primary outcome measure)
Overall survival and disease free survival [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827047 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Procedure: Total hemihepatic vascular exclusion
    A long vascular clamp is inserted along the midline of the anterior surface of the vena cava,proceed cranially up to the space between the right and the middle hepatic vein trunks. Two tapes are seized with the clamp passing between the anterior surface of the IVC and the liver parenchyma.One tape is use to pass around the hepatic parenchyma for occlusion of the bleeding from the remnant liver;the other is used to loop the right (or left )hepatic vein trunk and short hepatic vein,as well as inferior right hepatic vein,if present. Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection.Thus total hemihepatic vascular exclusion is achieved.
    Other Name: THHVE group
  • Procedure: Hemihepatic vascular Clamping
    Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection. Selective clamping can be achieved after carefully dissecting the right from the left hilar branches or after inserting a clamp between the right and left hilar branches without prior hilar dissection and looping the right or left portal structures with a tape.
    Other Name: Hemihepatic vascular Clamping group
  • Procedure: Pringle's Maneuver
    Hepatic pedicle 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
  • Active Comparator: Total Hemihepatic Vascular Exclusion
    Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.
    Intervention: Procedure: Total hemihepatic vascular exclusion
  • Experimental: Hemihepatic vascular Clamping
    Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.
    Intervention: Procedure: Hemihepatic vascular Clamping
  • Experimental: Pringle's Maneuver
    Patients with HCC received Pringle's Maneuver in hepatectomy.
    Intervention: Procedure: Pringle's Maneuver
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00827047
EHBH-RCT-2008-012
Yes
Not Provided
Not Provided
ShenFeng, Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
Not Provided
Study Chair: Feng Shen, M.D Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Eastern Hepatobiliary Surgery Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP