Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

NCT00827047 | Completed DMC

• 1 other identifier: EHBH-RCT-2008-012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; Surgical resection; total hemihepatic vascular exclusion; occlusion; bleeding; overall survival

Outcome Measures

Primary Outcomes (1)

• Overall survival and disease free survival

  1,2,or 3 years

Secondary Outcomes (1)

• Bleeding and blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications

  1,2,or 3 years

Study Arms (3)

Total Hemihepatic Vascular Exclusion

ACTIVE COMPARATOR

Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.

Procedure: Total hemihepatic vascular exclusion

Hemihepatic vascular Clamping

EXPERIMENTAL

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.

Procedure: Hemihepatic vascular Clamping

Pringle's Maneuver

EXPERIMENTAL

Patients with HCC received Pringle's Maneuver in hepatectomy.

Procedure: Pringle's Maneuver

Interventions

Total hemihepatic vascular exclusion 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.

Also known as: THHVE group

Total Hemihepatic Vascular Exclusion

Hemihepatic vascular Clamping 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.

Also known as: Hemihepatic vascular Clamping group

Hemihepatic vascular Clamping

Pringle's Maneuver 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.

Also known as: Pringle's Maneuver group

Pringle's Maneuver

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bites and Stings; Hemorrhage

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Shen, M.D

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)