Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827047
• Other study ID #: EHBH-RCT-2008-012
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: March 30, 2016
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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?

• Liver function in the Child-Pugh classification is A or B.

• Tumor AJCC stage is?or?.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival and disease free survival		1,2,or 3 years	No
Secondary	Bleeding and blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications		1,2,or 3 years	Yes