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Trial registered on ANZCTR


Registration number
ACTRN12611000962932
Ethics application status
Approved
Date submitted
17/08/2011
Date registered
8/09/2011
Date last updated
8/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomized controlled trial to compare
Pringle maneuver and selective hepatic vascular occlusion
in Liver resection involving the hepatocaval junction
Scientific title
compare the effect of selective hepatic vascular occlusion and Pringle maneuver in Liver resection
Secondary ID [1] 262868 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
controlling intraoperative bleeding in Liver resection 270583 0
Condition category
Condition code
Surgery 270754 270754 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
selective hepatic vascular occlusion is a method of inflow and outflow hepatic vascular occlusion in liver resection .It occurs once or twice for less than 1 hours which was decsided by the time of liver resection .
Intervention code [1] 269215 0
Treatment: Surgery
Intervention code [2] 269352 0
Treatment: Drugs
Comparator / control treatment
Pringle maneuver which is only inflow occlusion occurs once or twice for less than 1 hours which was decsided by the time of liver resection .
Control group
Active

Outcomes
Primary outcome [1] 279447 0
Blood loss(ml) ,Blood transfusion (units)
Timepoint [1] 279447 0
Intraoperation
Secondary outcome [1] 287669 0
1.Complications including postoperative hemmorrhage ,bile leak ,wound infection ,etc.
2.liver, renal function
Theywill be assessed including full blood count and ultrasonic,etc.
Timepoint [1] 287669 0
after surgery in one month

Eligibility
Key inclusion criteria
1. Corresponding to diagnostic standards of HCC; 2. Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins; 3. liver function in the Child-Pugh classification A or B; 4. Age
between 18~65years 5. Haven't taken any current treatment. 6. Understanding and being willing to sign the informed consent form
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.cannot be follow-up 2.severe liver, renal, or brain dysfunction; 3.with tumor thrombi in the main trunk of portal vein4. with tumor thrombi in the hepatic vein 5.with extrahepatic metastasis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
who had indications for partial hepatectomy at the Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital were considered included in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
create the random order for the allocation of subjects into different groups. Simple randomisation by using a randomisation table created by computerised sequence. If stratified allocation was employed in the study, the in hospital time used for the stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3795 0
China
State/province [1] 3795 0
shanghai

Funding & Sponsors
Funding source category [1] 269681 0
Hospital
Name [1] 269681 0
Eastern Hepatobiliary Surgery Hospital
Address [1] 269681 0
Second Military Medical University,changhai street Shanghai, China,200438
Country [1] 269681 0
China
Primary sponsor type
Hospital
Name
Eastern Hepatobiliary Surgery Hospital
Address
Second Military Medical University,changhai street Shanghai, China,200438
Country
China
Secondary sponsor category [1] 268719 0
University
Name [1] 268719 0
Second Military Medical University
Address [1] 268719 0
chanhhai street ,Shanghai, China,200438
Country [1] 268719 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271634 0
Ethic Committee of Shanghai Eastern Hepatobiliary Surgery Hospita
Ethics committee address [1] 271634 0
225 Changhai road, 200438, Shanghai, China
Ethics committee country [1] 271634 0
China
Date submitted for ethics approval [1] 271634 0
20/03/2008
Approval date [1] 271634 0
10/05/2008
Ethics approval number [1] 271634 0
ehbhky-2008013

Summary
Brief summary
To compare the effect of selective hepatic vascular exclusion (SHVE) and Pringle maneuver in Liver resection
To study the safety and efficacy of hepatic resection under selective hepatic vascular exclusion .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33038 0
Address 33038 0
Country 33038 0
Phone 33038 0
Fax 33038 0
Email 33038 0
Contact person for public queries
Name 16285 0
fusiyuan
Address 16285 0
225 Changhai Road, 200438, Shanghai,China
Country 16285 0
China
Phone 16285 0
+86 021 81875524
Fax 16285 0
Email 16285 0
fusiyuan1993@yahoo.com.cn
Contact person for scientific queries
Name 7213 0
zhouweiping
Address 7213 0
225 Changhai Road, 200438, Shanghai,China
Country 7213 0
China
Phone 7213 0
+86 021 81875524
Fax 7213 0
Email 7213 0
ehphwp@126.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary