Clinical trial NCT00820339: Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy
Official title: Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
hepatic vein
Surgical resection
occlusion
time to recurrence
overall survival
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.

Detailed description: Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying.

Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis.

Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins.

SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.

The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE can improve survival in HCC patients or not.

Eligibility criteria: Inclusion Criteria:

* Corresponding to diagnostic standards of HCC.
* Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins.
* liver function in the Child-Pugh classification A or B.
* Age between 18\~70 years.
* Haven't taken any current treatment.
* Understanding and being willing to sigh the informed consent form.

Exclusion Criteria:

* cannot be follow-up
* severe liver, renal, or brain dysfunction
* with tumor thrombi in the main trunk of portal vein
* with tumor thrombi in the hepatic vein
* with extrahepatic metastasis

Primary outcomes:
measure: Overall survival
timeFrame: 1,2,or 3 years
Secondary outcomes:
measure: Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications
timeFrame: 1,2,or 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Feng Shen, M.D.
role: STUDY_CHAIR
References: