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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Selective Hepatic Vascular Exclusion
Pringle's Maneuver
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, hepatic vein, Surgical resection, occlusion, time to recurrence, overall survival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Selective Hepatic Vascular Exclusion

Pringle's Maneuver

Arm Description

Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy.

Patients with HCC received Pringle's Maneuver in hepatectomy.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications

Full Information

First Posted
January 9, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00820339
Brief Title
Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy
Acronym
SHVE
Official Title
Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, hepatic vein, Surgical resection, occlusion, time to recurrence, overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selective Hepatic Vascular Exclusion
Arm Type
Active Comparator
Arm Description
Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy.
Arm Title
Pringle's Maneuver
Arm Type
Experimental
Arm Description
Patients with HCC received Pringle's Maneuver in hepatectomy.
Intervention Type
Procedure
Intervention Name(s)
Selective Hepatic Vascular Exclusion
Other Intervention Name(s)
SHVE group
Intervention Description
Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.
Intervention Type
Procedure
Intervention Name(s)
Pringle's Maneuver
Other Intervention Name(s)
Pringle's Maneuver group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1,2,or 3 years
Secondary Outcome Measure Information:
Title
Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications
Time Frame
1,2,or 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, M.D.
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

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