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
+44 020 8235 4225
b.saunders@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515176147
Study information
Scientific title
Randomised controlled trial of Narrow Band imaging with magnification (NBI) versus white light endoscopy for dysplasia detection in ulcerative colitis surveillance
Acronym
Study hypothesis
Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least pre-cancerous area (dysplasia associated lesion or mass, DALMs) than conventional colonoscopy using white light alone?
Ethics approval
Added 17 July 2008: approval granted by Harrow Research Ethics Committee REC 06/Q0408/10
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Not available in web format; for printed version please contact the investigators at the address below
Condition
Digestive System: Ulcerative colitis
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The study is to determine if the use of a narrow band of light can help detect more pre-cancerous or cancerous areas than the normal white light used for detection. The outcome measure is to determine the numbers of patients with at least one cancer in either group.
Secondary outcome measures
Added 17 July 2008:
1. Are more precancerous lesions found in total with NBI?
2. Are more advanced precancerous lesions found with NBI?
3. Are more patients found with more than one precancerous lesion with NBI?
4. How many lesions are successfully completely removed with endoscope?
Overall trial start date
01/03/2006
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with longstanding extensive colitis, with evidence of microscopic inflammation at a previous colonoscopy
2. Patients over 18
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
110 patients will be needed for each group, 220 in total
Participant exclusion criteria
Pre-intubation:
1. Pregnant patients
2. Severe active colitis
3. Those unwilling or unable to give consent
Pre-randomisation:
1. Those with poor bowel preparations
2. Unable to reach caecum due to stricture
Recruitment start date
01/03/2006
Recruitment end date
31/12/2008
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
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
Basic results (scientific)
Publication list
1. 2006 case report in: https://www.ncbi.nlm.nih.gov/pubmed/16966701
2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22613903
Publication citations
-
Case report
East JE, Suzuki N, von Herbay A, Saunders BP, Narrow band imaging with magnification for dysplasia detection and pit pattern assessment in ulcerative colitis surveillance: a case with multiple dysplasia associated lesions or masses., Gut, 2006, 55, 10, 1432-1435, doi: 10.1136/gut.2005.087171.