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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival and disease free survival

Outcome Time Frame:

1,2,or 3 years

Safety Issue:

No

Principal Investigator

Feng Shen, M.D

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2008-012

NCT ID:

NCT00827047

Start Date:

January 2009

Completion Date:

December 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • Surgical resection
  • total hemihepatic vascular exclusion
  • occlusion
  • bleeding
  • overall survival
  • Carcinoma
  • Carcinoma, Hepatocellular

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