Contact information
Type
Scientific
Primary contact
Dr Brian P Saunders
ORCID ID
Contact details
The Wolfson Unit 2nd Floor
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
+44 (0)20 8235 4225
b.saunders@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515176146
Study information
Scientific title
Acronym
Study hypothesis
Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least one pre-cancerous polyp (adenoma) than conventional colonoscopy using white light alone?
The study is to determine if narrow band imaging is better for detecting flat polyps than conventional diagnosis. A high detection rate of flat polyps would indicate that this type of surveillance should be used in the national cancer screening programme.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Colonoscopy
Intervention
Narrow band imaging (NBI) versus standard endoscopy.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Categorical data will be compared with chi-squared test, t-testing on Mann-Whitney U test will be used for continuous data depending on normality
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/01/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients over 18 assessed as fit for routine colonoscopy
2. Patients attending for screening or surveillance colonoscopy
3. At least three adenomas or one adenoma >10 mm at previous colonoscopy post colorectal cancer resection screening with positive faecal occult blood tests
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
107 patients will be needed for each group, 214 in total. Recruitment completed Summer 2008
Participant exclusion criteria
Pre-intubation:
1. Patients with known colitis or polyposis syndromes
2. Unable or unwilling to give consent
Pre-caecum to randomisation:
1. Those with poor bowel preparation
2. Unable to reach caecum due to stricture
Recruitment start date
20/01/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Wolfson Unit 2nd Floor
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22958651
Publication citations
-
Results
East JE, Ignjatovic A, Suzuki N, Guenther T, Bassett P, Tekkis PP, Saunders BP, A randomized, controlled trial of narrow-band imaging vs high-definition white light for adenoma detection in patients at high risk of adenomas., Colorectal Dis, 2012, 14, 11, e771-8, doi: 10.1111/codi.12014.