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Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total hemihepatic vascular exclusion
Hemihepatic vascular Clamping
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, Surgical resection, total hemihepatic vascular exclusion, occlusion, bleeding, overall survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

5Inclusion 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

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Total Hemihepatic Vascular Exclusion

Hemihepatic vascular Clamping

Pringle's Maneuver

Arm Description

Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.

Patients with HCC received Pringle's Maneuver in hepatectomy.

Outcomes

Primary Outcome Measures

Overall survival and disease free survival

Secondary Outcome Measures

Bleeding and blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications

Full Information

First Posted
January 21, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00827047
Brief Title
Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment
Official Title
A Prospective Randomized Controlled Trial of Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment
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
December 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
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.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 hemihepatic vascular clamping and Pringle maneuver.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, Surgical resection, total hemihepatic vascular exclusion, occlusion, bleeding, overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Hemihepatic Vascular Exclusion
Arm Type
Active Comparator
Arm Description
Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.
Arm Title
Hemihepatic vascular Clamping
Arm Type
Experimental
Arm Description
Patients with HCC received Hemihepatic vascular Clamping 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)
Total hemihepatic vascular exclusion
Other Intervention Name(s)
THHVE group
Intervention Description
A long vascular clamp is inserted along the midline of the anterior surface of the vena cava,proceed cranially up to the space between the right and the middle hepatic vein trunks. Two tapes are seized with the clamp passing between the anterior surface of the IVC and the liver parenchyma.One tape is use to pass around the hepatic parenchyma for occlusion of the bleeding from the remnant liver;the other is used to loop the right (or left )hepatic vein trunk and short hepatic vein,as well as inferior right hepatic vein,if present. Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection.Thus total hemihepatic vascular exclusion is achieved.
Intervention Type
Procedure
Intervention Name(s)
Hemihepatic vascular Clamping
Other Intervention Name(s)
Hemihepatic vascular Clamping group
Intervention Description
Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection. Selective clamping can be achieved after carefully dissecting the right from the left hilar branches or after inserting a clamp between the right and left hilar branches without prior hilar dissection and looping the right or left portal structures with a tape.
Intervention Type
Procedure
Intervention Name(s)
Pringle's Maneuver
Other Intervention Name(s)
Pringle's Maneuver group
Intervention Description
Hepatic pedicle 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 and disease free survival
Time Frame
1,2,or 3 years
Secondary Outcome Measure Information:
Title
Bleeding and 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
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
5Inclusion 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
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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Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

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