Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000154909
Ethics application status
Not yet submitted
Date submitted
8/02/2011
Date registered
9/02/2011
Date last updated
9/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Detecting liver injury in inflammatory bowel disease using transient elastography.
Scientific title
Detecting liver injury by measuring liver stiffness using transient elastography in inflammatory bowel disease patients.
Secondary ID [1] 253571 0
No secondary ID available
Universal Trial Number (UTN)
U1111-1119-3832
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver injury in patients with inflammatory bowel disease. 261128 0
Condition category
Condition code
Oral and Gastrointestinal 259282 259282 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measuring liver stiffness in kilopascals using transient elastography (FibroScan) in both Crohn's disease and ulcerative colitis patients and comparing them to healthy controls.
Each FibroScan measurement will only take 5 minutes for 10 successful acquisitions. This will only be done once. If the patient has an abnormally high reading e.g >8 this will be repeated in 3 months to verify the reading.
Intervention code [1] 258000 0
Not applicable
Comparator / control treatment
Aged matched healthy controls to also get once off transient elastography reading (10 successful acquisition)
Control group
Active

Outcomes
Primary outcome [1] 262092 0
Liver stiffness measured in kilopascals using transient elastography in Crohn's disease, ulcerative colitis and age matched healthy control patients. Transient elastography will be assessed using the FibroScan machine.
Timepoint [1] 262092 0
Primary outcome will be measured at recruitment (time=0). This is a crosssectional prevalence study thus patients will not have a second follow up reading unless the first is very abnormal.
Secondary outcome [1] 273141 0
nil
Timepoint [1] 273141 0
nil

Eligibility
Key inclusion criteria
All consecutive consenting patients with a confirmed diagnosis of inflammatory bowel disease. Control patients will be age matched according the following cohorts <25 y.o, 25-35, 35-50 and >50, with no history of liver disease and drink less than 14std drinks per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unconfirmed diagnosis of inflammatory bowel dsiease.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258460 0
Commercial sector/Industry
Name [1] 258460 0
Ferring (via Gastroenterological Society of Australia- GESA)
Country [1] 258460 0
Australia
Primary sponsor type
Individual
Name
Dr Lena Thin
Address
T block School of Medicine and Pharmacology
Fremantle Hospital
Alma St, Fremantle 6160
Western Australia
Country
Australia
Secondary sponsor category [1] 257602 0
Individual
Name [1] 257602 0
Professor John Olynyk
Address [1] 257602 0
T block School of Medicine and Pharmacology
Fremantle Hospital
Alma St, Fremantle 6160
Western Australia
Country [1] 257602 0
Australia
Secondary sponsor category [2] 257603 0
Individual
Name [2] 257603 0
Professor Ian Lawrance
Address [2] 257603 0
Centre for Inflammatory Bowel Disease
T block School of Medicine and Pharmacology
Fremantle Hospital
Alma St, Fremantle 6160
Western Australia
Country [2] 257603 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260438 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 260438 0
G Block, Room G5.27B
Fremantle Hospital & Health Service
PO Box 480, FREMANTLE WA 6959
Ethics committee country [1] 260438 0
Australia
Date submitted for ethics approval [1] 260438 0
09/02/2011
Approval date [1] 260438 0
Ethics approval number [1] 260438 0

Summary
Brief summary
Hepatobiliary disease is a common manifestation of inflammatory bowel disease (IBD). Usually this is apparent by the development of abnormal liver function tests (LFT). In the majority of cases deranged liver tests are transient, can be related to the activity of the inflammatory bowel disease and have no clinical sequalae. However, There are several other causes for deranged LFT’s in IBD which may lead to permanent scarring of the liver. A scarred or fibrotic liver often may not declare itself by abnormal liver tests and transient elastography (TE) is a non invasive method of measuring liver stiffness now used widely in research and clinical practice. In the field of hepatitis C, it is largely replacing the need for a liver biopsy to exclude advance fibrosis and cirrhosis. In this project we seek to find out the prevalence of liver injury in IBD patients by measuring liver stiffness using an operator independent machine called FibroScan (RT).
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32190 0
Address 32190 0
Country 32190 0
Phone 32190 0
Fax 32190 0
Email 32190 0
Contact person for public queries
Name 15437 0
Dr Lena Thin
Address 15437 0
T block, School of Medicine and Pharmacology
Fremantle Hospital
Alma Street, Fremantle 6160
Western Australia.
Country 15437 0
Australia
Phone 15437 0
+61 8 9431 2698
Fax 15437 0
+61 8 9431 3160
Email 15437 0
[email protected]
Contact person for scientific queries
Name 6365 0
Dr Lena Thin
Address 6365 0
T block, School of Medicine and Pharmacology
Fremantle Hospital
Alma Street, Fremantle 6160
Western Australia.
Country 6365 0
Australia
Phone 6365 0
9431 2698
Fax 6365 0
Email 6365 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.