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Trial registered on ANZCTR


Registration number
ACTRN12609000651280
Ethics application status
Not yet submitted
Date submitted
29/07/2009
Date registered
3/08/2009
Date last updated
3/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Study to Investigate the Correlation between Wedged Hepatic Venous Pressure and Direct Portal Venous Pressure during formation or revision of Transjugular Intrahepatic Portosystemic Shunt
Scientific title
In patients undergoing formation or revision of a transjugular intrahepatic portosystemic shunt, does the wedged hepatic vein pressure acurately reflect the direct portal venous pressure?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cirrhosis 243396 0
Portal Hypertension 243397 0
Hepatic Vein Wedge Pressure 243398 0
Condition category
Condition code
Oral and Gastrointestinal 239705 239705 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement of wedged hepatic vein pressure. This involves wedging a balloon catheter in a hepatic vein branch and measuring the pressure. This is done immediately prior to the formation of the Transjugular Intrahepatic Portosystemic Shunt. When the portal vein is accessed by the shunt, the direct portal vein pressure is measured. This will be compared to the initial hepatic vein wedge pressure measurements for the purpose of teh study. These measurements will add approximately 5 minutes to the scheduled procedure (which takes approximately 40 minutes in total)
Intervention code [1] 237036 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240475 0
Degree of correlation between wedged hepatic vein pressure and direct portal pressure. This will be assessed by measuring hepatic vein wedge pressures at multiple sites then measuring the direct portal venous pressure once the transjugular intrahepatic portosystemic shunt has been formed. The average of the wedged hepatic vein pressures will be compared to the direct portal vein pressure.
Timepoint [1] 240475 0
At time of formation or revision of transjugular intrahepatic portosystemic shunt
Secondary outcome [1] 257016 0
Nil
Timepoint [1] 257016 0
Nil

Eligibility
Key inclusion criteria
Age above 18 years
Patient undergoing formation or revision of Transjugular Intrahepatic POrtosystemic Shunt
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients scheduled to undergo formation or revision of a Transjugular Intrahepatic Portosystemic Shunt at a single centre will be invited to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237411 0
Hospital
Name [1] 237411 0
Royal Prince Alfred Hospital
Country [1] 237411 0
Australia
Primary sponsor type
Individual
Name
Richard Waugh
Address
Radiology Department
Royal Prince Alfred Hospital
Missenden Rd Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 236908 0
Individual
Name [1] 236908 0
Ines Nikolovski
Address [1] 236908 0
Royal Prince Alfred Hospital
Missenden Rd Camperdown
NSW 2050
Country [1] 236908 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239543 0
Ethics committee address [1] 239543 0
Ethics committee country [1] 239543 0
Date submitted for ethics approval [1] 239543 0
26/08/2009
Approval date [1] 239543 0
Ethics approval number [1] 239543 0

Summary
Brief summary
The intent of the study is to determine the accuracy of currently accepted methods of measurement of degree of liver cirrhosis and portal hypertension. This would primarily benefit patients indirectly and may lead to improvement in the techniques used to measure the severity of liver cirrhosis in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29984 0
Address 29984 0
Country 29984 0
Phone 29984 0
Fax 29984 0
Email 29984 0
Contact person for public queries
Name 13231 0
Ines Nikolovski
Address 13231 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 13231 0
Australia
Phone 13231 0
+61 2 9515 6111
Fax 13231 0
Email 13231 0
[email protected]
Contact person for scientific queries
Name 4159 0
Richard Waugh
Address 4159 0
Radiology Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown, 2050
Country 4159 0
Australia
Phone 4159 0
+61 2 9515 7444
Fax 4159 0
Email 4159 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.