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NCT Number: NCT00827047

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: THHVE group

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.

Other names: Hemihepatic vascular Clamping group

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.

Other names: Pringle's Maneuver group

Primary outcomes

  1. Overall survival and disease free survival

    Time frame: 1,2,or 3 years

Secondary outcomes

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

    Time frame: 1,2,or 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial of Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 22, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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