Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Hemihepatic vascular Clamping; Procedure: Pringle's Maneuver; Procedure: Total hemihepatic vascular exclusion

• Registration Number: NCT00827047
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2010-12
• Study Completion: 2012-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemihepatic vascular Clamping	Hemihepatic vascular Clamping	Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.
Pringle's Maneuver	Pringle's Maneuver	Patients with HCC received Pringle's Maneuver in hepatectomy.
Total Hemihepatic Vascular Exclusion	Total hemihepatic vascular exclusion	Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.

Primary Outcome Measures

Name	Time	Method
Overall survival and disease free survival	1,2,or 3 years

Secondary Outcome Measures

Name	Time	Method
Bleeding and blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications	1,2,or 3 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China