Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000018819
Ethics application status
Approved
Date submitted
17/02/2009
Date registered
5/01/2012
Date last updated
5/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
New imaging technologies in the detection of colitis related colon cancer
Scientific title
A prospective study assessing the outcomes of chromoendoscopy and narrow band imaging in colitis surveillance for dysplasia
Secondary ID [1] 259808 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysplasia in Colitis 4352 0
Condition category
Condition code
Oral and Gastrointestinal 4596 4596 0 0
Inflammatory bowel disease
Cancer 285661 285661 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergo standard colonoscopy until the caecum is reached. Only a single colonoscopy will be performed on each patient (one-off).

Once the caecum is reached, all patients undergo sequential examination of colonic segments (as defined by the hepatic and splenic flexures) initially by NBI and then by chromoendoscopy.

The NBI and chromoendoscopy examinations are undertaken by two independent endoscopists.

NBI is activated by selecting a button on the standard colonoscope. It is then deactivated at the end of the examination of that segment.

There are no time limits imposed on the examination times however typically each examination takes 2-3minutes to examine.
Intervention code [1] 4084 0
Early detection / Screening
Intervention code [2] 264238 0
Prevention
Comparator / control treatment
Once a segment is examined by NBI then an independent endoscopist blinded to the results of the NBI examination examines the same segment using choromoendoscopy.

Chromoendoscopy involves applying 0.1% methylene blue solution to the bowel lining using a spray catheter and then examining that area.

There are no time limits imposed on the examination times however typically each examination takes 2-3minutes to examine.
Control group
Active

Outcomes
Primary outcome [1] 5472 0
Diagnostic yield for dysplasia
Timepoint [1] 5472 0
At conclusion of the colonoscopy, the diagnostic yield for dysplasia will be measured for NBI and chromoendoscopy.
Secondary outcome [1] 273608 0
Accuracy of the Kudo classification by NBI in predicting neoplasia, calculated by comparing the prediction of neoplastic versus non neoplastic classification by NBY to actual histology.
Timepoint [1] 273608 0
At the conclusion of the study, the accuracy of the Kudo classification by NBI of any identified lesions will be calculated.

Eligibility
Key inclusion criteria
Age 18 and above
Long standing colitis (8 years or more)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4532 0
Hospital
Name [1] 4532 0
St Vincents Hospital
Country [1] 4532 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital
Address
41 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 263820 0
None
Name [1] 263820 0
Address [1] 263820 0
Country [1] 263820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6584 0
St Vincent's Hospital HREC A
Ethics committee address [1] 6584 0
Ethics committee country [1] 6584 0
Australia
Date submitted for ethics approval [1] 6584 0
17/02/2009
Approval date [1] 6584 0
Ethics approval number [1] 6584 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29304 0
Address 29304 0
Country 29304 0
Phone 29304 0
Fax 29304 0
Email 29304 0
Contact person for public queries
Name 12551 0
Dr Marios Efthymiou
Address 12551 0
St Vincents Hospital
41 Victoria Parade, Fitzroy, VIC 3065
Country 12551 0
Australia
Phone 12551 0
+613 92884410
Fax 12551 0
+613 86781032
Email 12551 0
mariosefthymiou@hotmail.com
Contact person for scientific queries
Name 3479 0
Dr Marios Efthymiou
Address 3479 0
St Vincents Hospital
41 Victoria Parade, Fitzroy, VIC 3065
Country 3479 0
Australia
Phone 3479 0
+613 92884410
Fax 3479 0
+613 86781032
Email 3479 0
mariosefthymiou@hotmail.com

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
SourceTitleYear of PublicationDOI
Dimensions AIChromoendoscopy versus Narrow Band Imaging for Colonic Surveillance in Inflammatory Bowel Disease2013https://doi.org/10.1097/mib.0b013e31829637b9
N.B. These documents automatically identified may not have been verified by the study sponsor.