Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Selective Hepatic Vascular Exclusion
* Procedure: Pringle's Maneuver


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selective Hepatic Vascular Exclusion<br>Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy. | Procedure: Selective Hepatic Vascular Exclusion<br>* Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.<br>* Other names: SHVE group;|
| Experimental: Pringle's Maneuver<br>Patients with HCC received Pringle's Maneuver in hepatectomy. | Procedure: Pringle's Maneuver<br>* Hepatic pedical 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.<br>* Other names: Pringle's Maneuver group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1,2,or 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications |  | 1,2,or 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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time to recurrence, hepatocellular carcinoma, hepatic vein, Surgical resection, occlusion, overall survival