Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000206224
Ethics application status
Approved
Date submitted
17/04/2009
Date registered
24/04/2009
Date last updated
24/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Randomized Controlled Trial to Compare Hemihepatic Vascular Inflow Occlusion, Portal Vein Inflow Occlusion and Pringle Maneuver in Partial Hepatectomy
Scientific title
A Prospective Randomized Controlled Trial to Compare the operative blood loss, postoperative liver function changees of Hemihepatic Vascular Inflow Occlusion, Portal Vein Inflow Occlusion and Pringle Maneuver in Partial Hepatectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular control technique for partial hepatectomy 4619 0
Condition category
Condition code
Surgery 4919 4919 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hemihepatic Vascular Inflow Occlusion group (In hemihepatic vascular inflow occlusion, the portal vein, hepatic artery, and bile duct were dissected in the hilum by lowering the liver plate. Either the right or left portal pedicle was isolated en bloc and was controlled with a tourniquet or Santinsky clamp. The estimated duration is around 30 minutes.)
Portal Vein Inflow Occlusion group (In portal vein inflow occlusion, the portal vein was isolated and occluded with a tourniquet. The estimated duration is around 30 minutes.)
Intervention code [1] 4380 0
Treatment: Surgery
Comparator / control treatment
Pringel Maneuver group (In Pringle maneuver group, the entire hepaticoduodenal ligament was encircled and tightened with a rubber tourniquet. The estimated duration is around 30 minutes.)
Control group
Active

Outcomes
Primary outcome [1] 5766 0
Intraoperative blood loss (calculate the suction drain output and weight of soaked gauze)
Timepoint [1] 5766 0
After operation (partial hepatectomy)
Primary outcome [2] 5767 0
Post-operative liver function changes (check blood for liver function parameters)
Timepoint [2] 5767 0
On operation day, post-operative day 1, 3, 7
Secondary outcome [1] 241722 0
Operating time
Timepoint [1] 241722 0
After operation (partial hepatectomy)
Secondary outcome [2] 241723 0
Morbidty (clinical assessment +/- imaging and documentation e.g. post-operative bleeding, bile leak, intrabdominal collection) and mortality of surgery
Timepoint [2] 241723 0
After patient discharge from hospital

Eligibility
Key inclusion criteria
(1) Elective liver resection;
(2) No other concomitant major surgical procedures, such as bowel or bile duct resection;
(3) Compensated cirrhosis with Child-Pugh class A or B.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contralateral hepatic resection was required;
2. Total or selective vascular inflow/outflow occlusion was required because of tumor extent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 1734 0
China
State/province [1] 1734 0

Funding & Sponsors
Funding source category [1] 4801 0
Self funded/Unfunded
Name [1] 4801 0
Country [1] 4801 0
Primary sponsor type
Hospital
Name
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital
Address
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 225 Changhai Street, 200438, Shanghai, China
Country
China
Secondary sponsor category [1] 4335 0
None
Name [1] 4335 0
Address [1] 4335 0
Country [1] 4335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6848 0
Institutional Review Board of the Eastern Hepatobiliary Hospital
Ethics committee address [1] 6848 0
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 225 Changhai Street, 200438, Shanghai, China
Ethics committee country [1] 6848 0
China
Date submitted for ethics approval [1] 6848 0
Approval date [1] 6848 0
03/06/2006
Ethics approval number [1] 6848 0
ZD2006002-P1

Summary
Brief summary
The impact of blood loss during liver resection and the need for perioperative blood transfusions have been shown to negatively impact perioperative morbidity and mortality as well as long term outcomes. The objective of this study is To compare the perioperative outcomes of partial hepatectomy using hemihepatic vascular inflow occlusion, portal vein inflow occlusion. and Pringle maneuver.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29502 0
Address 29502 0
Country 29502 0
Phone 29502 0
Fax 29502 0
Email 29502 0
Contact person for public queries
Name 12749 0
Zhou Wei-ping
Address 12749 0
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 225 Changhai Street, 200438, Shanghai, China
Country 12749 0
China
Phone 12749 0
+86-21-25070792
Fax 12749 0
Email 12749 0
[email protected]
Contact person for scientific queries
Name 3677 0
Lau Wan Yee
Address 3677 0
Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
Country 3677 0
China
Phone 3677 0
+852-2632 2626
Fax 3677 0
Email 3677 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.