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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/NCT05935124




Registration number
NCT05935124
Ethics application status
Date submitted
28/06/2023
Date registered
7/07/2023
Date last updated
7/07/2023

Titles & IDs
Public title
A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy
Scientific title
A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy
Secondary ID [1] 0 0
4222
Universal Trial Number (UTN)
Trial acronym
WLEvsB-NBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenoma Colon 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
Oral and Gastrointestinal 0 0 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
Diagnosis / Prognosis - WLE first, then B-NBI

Other: First withdrawal - White light endoscopy - white light (WLE) high definition colonoscope (Olympus 190 series) first and then B-NBI

Other: First withdrawal - Bright Narrow Band Imagin - B-NBI first and then WLE with the same colonoscope.


Diagnosis / Prognosis: WLE first, then B-NBI
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of right sided polyp detection with WLE and B-NBI
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
Rate of the detection of SSPs in the right colon with WLE and B-NBI
Timepoint [1] 0 0
1 day

Eligibility
Key inclusion criteria
Asymptomatic subjects undergoing screening colonoscopy, age > 50. Avaverage risk subjects
defined as those without a personal history of inflammatory bowel disease, colon adenoma or
cancer or family history of FAP or Familial non-polyposis syndrome or first degree
relatives having diagnosed to have colo-rectal carcinoma, no colonoscopy in past 5 years
and, ability to provide a written consent to trial participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- unable to consent

Study design
Purpose of the study
Diagnosis
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized controlled crossover study to determine if narrow band imaging or white light
endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing
screening colonoscopy
Trial website
https://clinicaltrials.gov/ct2/show/NCT05935124
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
Kathleen Goodrick, BN
Address 0 0
Country 0 0
Phone 0 0
8890555
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05935124