Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001293752
Ethics application status
Approved
Date submitted
30/10/2012
Date registered
21/11/2013
Date last updated
25/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The importance of Microcirculation in Liver resection
Scientific title
The importance of hepatic microcirculation and the pathophysiological role of endothelia-1 in major liver resection
Secondary ID [1] 281474 0
Nil
Universal Trial Number (UTN)
U1111-1136-5261
Trial acronym
MERP-RESECTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing liver resection 287733 0
Condition category
Condition code
Surgery 288075 288075 0 0
Other surgery
Inflammatory and Immune System 288175 288175 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 290733 290733 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Forty patients undergoing major liver resection will be included in the study. Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected.
A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used before liver resection and 30 minutes after liver resection..
It is hand-held probe with a sterile extension for direct contact with liver parenchyma. Portal vein and hepatic artery flow will be measured intraoperatively before resection and 30 min after liver resection..
Liver biopsies are performed before resection and 30 min after liver resection.. to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having liver resection.
Intervention code [1] 285978 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288279 0
Correlation between microcirculation and portal vein and hepatic artery flow.
Timepoint [1] 288279 0
Before and after liver resection
Secondary outcome [1] 299744 0
Liver functional test
Timepoint [1] 299744 0
Pre operative and Post operative day 1-3-5

Eligibility
Key inclusion criteria
patients undergoing major liver resection
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing minor resection

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286238 0
Hospital
Name [1] 286238 0
Upper gastro-intestinal surgery unit
Country [1] 286238 0
Australia
Primary sponsor type
Hospital
Name
Upper gastro-intestinal unit surgery unit
Address
Royal Prince Alfred hospital, missenden road
camperdown 2050
Country
Australia
Secondary sponsor category [1] 285045 0
None
Name [1] 285045 0
Address [1] 285045 0
Country [1] 285045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288318 0
Ethics review Committee
Ethics committee address [1] 288318 0
royal prince Alfred Hospita
Camperdown, 2050
Ethics committee country [1] 288318 0
Australia
Date submitted for ethics approval [1] 288318 0
31/10/2012
Approval date [1] 288318 0
20/03/2013
Ethics approval number [1] 288318 0
hrec/c12/rpah/530

Summary
Brief summary
Forty patients undergoing major liver resection will be included in the study. Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected.
A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used.
It is hand-held probe with a sterile extension for direct contact with liver parenchyma. Portal vein and hepatic artery flow will be measured intraoperatively.
Liver biopsies are performed to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having liver resection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34897 0
Dr Carlo Pulitano
Address 34897 0
Royal Prince Alfred Hospital
Missenden road
Camperdown 2050 NSW
Country 34897 0
Australia
Phone 34897 0
+ 61 458 003 482
Fax 34897 0
Email 34897 0
[email protected]
Contact person for public queries
Name 18144 0
Dr Carlo Pulitano
Address 18144 0
Royal Prince Alfred Hospital
Missenden road
Camperdown 2050 NSW
Country 18144 0
Australia
Phone 18144 0
+ 61 458 003 482
Fax 18144 0
Email 18144 0
[email protected]
Contact person for scientific queries
Name 9072 0
Dr Carlo Pulitano
Address 9072 0
Royal Prince Alfred Hospital
Missenden road
Camperdown 2050 NSW
Country 9072 0
Australia
Phone 9072 0
+ 61 458 003 482
Fax 9072 0
Email 9072 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.