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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01737567
Registration number
NCT01737567
Ethics application status
Date submitted
27/11/2012
Date registered
29/11/2012
Date last updated
3/07/2023
Titles & IDs
Public title
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
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Scientific title
A Randomised Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Colonic Adenomas in Asymptomatic Subjects Undergoing Screening Colonoscopy.
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Secondary ID [1]
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HREC2011/12/4.9 (3395)
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Secondary ID [2]
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HREC/11/WMEAD/223
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Universal Trial Number (UTN)
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Trial acronym
WLEvB-NBI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colonic Adenomas
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Bright Narrow Band Imaging.
Other interventions - White Light Endoscopy
Experimental: Bright Narrow Band Imaging - Use of B-NBI to detect colonic adenomas.
Active Comparator: White Light Endoscopy - Use of White Light Endoscopy to detect colonic adenomas.
Other interventions: Bright Narrow Band Imaging.
Using Bright Narrow Band Imaging to detect colonic adenomas.
Other interventions: White Light Endoscopy
Use of White Light Endoscopy to detect colonic adenomas.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Improvement in detection of colorectal adenomas.
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Assessment method [1]
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It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.
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Timepoint [1]
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One year
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Secondary outcome [1]
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Improvement of histological prediction
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Assessment method [1]
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It is anticipated that the use of Bright Narrow Band Imaging will significantly improve the histological detection of colonic adenomas when detected as opposed to White Light Endoscopy.
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Timepoint [1]
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One year
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Eligibility
Key inclusion criteria
- Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk
subjects and, ability to provide a written consent to trial participation.
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Minimum age
50
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- personal history of inflammatory bowel disease, colon adenoma or cancer
- family history of FAP or Familial nonpolyposis syndrome
- first degree relatives having diagnosed to have colorectal carcinoma
- no colonoscopy in past 5 years
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Study design
Purpose of the study
Screening
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
600
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Endoscopy Unit - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Professor Michael Bourke
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of
chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band
imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing
White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable
advantage to using one or the other for lesion detection and assessment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01737567
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01737567
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