The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01737567




Registration number
NCT01737567
Ethics application status
Date submitted
27/11/2012
Date registered
29/11/2012
Date last updated
5/07/2019

Titles & IDs
Public title
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
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.
Secondary ID [1] 0 0
HREC2011/12/4.9 (3395)
Secondary ID [2] 0 0
HREC/11/WMEAD/223
Universal Trial Number (UTN)
Trial acronym
WLEvB-NBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Adenomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in detection of colorectal adenomas. - It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
Improvement of histological prediction - 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.
Timepoint [1] 0 0
One year

Eligibility
Key inclusion criteria
- Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk
subjects and, ability to provide a written consent to trial participation.
Minimum age
50 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Screening
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01737567
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Sonson, BN
Address 0 0
Country 0 0
Phone 0 0
98455555
Fax 0 0
Email 0 0
westmeadendoscopyresearch@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01737567