Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Pringle's Maneuver; Procedure: Total hemihepatic vascular exclusion; Procedure: Hemihepatic vascular Clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT00827047

EHBH-RCT-2008-012

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Total Hemihepatic Vascular Exclusion

Active Comparator group

Description:

Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.

Treatment:

Procedure: Total hemihepatic vascular exclusion

Hemihepatic vascular Clamping

Experimental group

Description:

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.

Treatment:

Procedure: Hemihepatic vascular Clamping

Pringle's Maneuver

Experimental group

Description:

Patients with HCC received Pringle's Maneuver in hepatectomy.

Treatment:

Procedure: Pringle's Maneuver