Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000604808
Ethics application status
Approved
Date submitted
3/06/2012
Date registered
5/06/2012
Date last updated
5/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can blood levels of Endothelin-1 predict liver function after liver resection?
Scientific title
A study to determine whether serum levels of Endothelin-1 have any prognostic utility in predicting liver function post liver resection
Secondary ID [1] 280607 0
Nil
Universal Trial Number (UTN)
U1111-1131-4301
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative liver function and serum level of endothelin 1 and tumor necrosis factor alpha 286620 0
Condition category
Condition code
Surgery 286894 286894 0 0
Other surgery
Oral and Gastrointestinal 286899 286899 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective study, post operative liver functional test and serum level of endothelin 1 and TNF are measured preoperatively an post operative day 1, 2 ,5
Intervention code [1] 285001 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287248 0
was to determine whether ET-1 levels has any prognostic utility in predicting PLF. Inflammatory response measured with serum level of tumor necrosis factor
Timepoint [1] 287248 0
Serial post-operative serum ET-1 levels and TNF are measured preoperativelly and post operative day 1,2 and 5
Secondary outcome [1] 297736 0
nil
Timepoint [1] 297736 0
nil

Eligibility
Key inclusion criteria
Liver resection
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no liver resection

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 4344 0
Italy
State/province [1] 4344 0

Funding & Sponsors
Funding source category [1] 285365 0
Hospital
Name [1] 285365 0
Department of Surgery, Hepatobiliary Unit, Scientific Institute San Raffaele
Country [1] 285365 0
Italy
Primary sponsor type
Hospital
Name
Department of Surgery, Hepatobiliary Unit, Scientific Institute San Raffaele
Address
Via Olgettina 60, 20132 Milan - Italy
Country
Italy
Secondary sponsor category [1] 284219 0
None
Name [1] 284219 0
Address [1] 284219 0
Country [1] 284219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287380 0
Ethical comitee
Ethics committee address [1] 287380 0
Via Olgettina 60, 20132 Milan - Italy
Ethics committee country [1] 287380 0
Italy
Date submitted for ethics approval [1] 287380 0
Approval date [1] 287380 0
01/05/2010
Ethics approval number [1] 287380 0

Summary
Brief summary
Postoperative liver failure (PLF) remains a relatively frequent and life-threatening complication after liver resection. Recent studies have demonstrated that besides the residual liver volume, damage of the microcirculation secondary to increased portal blood flow is a main determinant of PLF. Endothelin-1 (ET-1) is a multimodular mediator produced primarily by sinusoidal endothelial cells and is known to play a key role in the regulation of hepatic microcirculation and ischemia reperfusion injury. The aim of this study was to determine whether ET-1 levels has any prognostic utility in predicting PLF.
Trial website
Trial related presentations / publications
Oral presentation at International hepatobiliary surgery congress, july 1-5, 2012, Paris, France.
The paper will be submitted at british journal of surgery
Public notes

Contacts
Principal investigator
Name 34256 0
Address 34256 0
Country 34256 0
Phone 34256 0
Fax 34256 0
Email 34256 0
Contact person for public queries
Name 17503 0
Carlo Pulitano
Address 17503 0
Department of Surgery, Hepatobiliary Unit, Scientific Institute San Raffaele,
Via Olgettina 60, 20132 Milan - Italy
Country 17503 0
Italy
Phone 17503 0
+39-02-2643-7808
Fax 17503 0
Email 17503 0
[email protected]
Contact person for scientific queries
Name 8431 0
Carlo Pulitano
Address 8431 0
Department of Surgery, Hepatobiliary Unit, Scientific Institute San Raffaele,
Via Olgettina 60, 20132 Milan - Italy
Country 8431 0
Italy
Phone 8431 0
+39-02-2643-7808
Fax 8431 0
Email 8431 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.