Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy (SHVE)

Naval Military Medical University (Second Military Medical University)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Selective Hepatic Vascular Exclusion; Procedure: Pringle's Maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT00820339

EHBH-RCT-2008-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Selective Hepatic Vascular Exclusion

Active Comparator group

Description:

Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy.

Treatment:

Procedure: Selective Hepatic Vascular Exclusion

Pringle's Maneuver

Experimental group

Description:

Patients with HCC received Pringle's Maneuver in hepatectomy.

Treatment:

Procedure: Pringle's Maneuver