Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

NCT ID: NCT00827047

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total Hemihepatic Vascular Exclusion

Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.

Group Type: ACTIVE_COMPARATOR

Total hemihepatic vascular exclusion

Intervention Type: PROCEDURE

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.

Hemihepatic vascular Clamping

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.

Group Type: EXPERIMENTAL

Hemihepatic vascular Clamping

Intervention Type: PROCEDURE

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.

Pringle's Maneuver

Patients with HCC received Pringle's Maneuver in hepatectomy.

Group Type: EXPERIMENTAL

Pringle's Maneuver

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

THHVE group; Hemihepatic vascular Clamping group; Pringle's Maneuver group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Shen, M.D

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBH-RCT-2008-012

Identifier Type: -

Identifier Source: org_study_id