Randomised controlled trial of Narrow Band imaging with magnification (NBI) versus white light endoscopy for dysplasia detection in ulcerative colitis surveillance

ISRCTN ISRCTN72236016
DOI https://doi.org/10.1186/ISRCTN72236016
Secondary identifying numbers N0515176147
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
14/09/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian P Saunders
Scientific

The Wolfson Unit 2nd Floor
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Phone +44 020 8235 4225
Email b.saunders@imperial.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeDiagnostic
Participant information sheet Not available in web format; for printed version please contact the investigators at the address below
Scientific titleRandomised controlled trial of Narrow Band imaging with magnification (NBI) versus white light endoscopy for dysplasia detection in ulcerative colitis surveillance
Study objectivesDoes 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(s)Added 17 July 2008: approval granted by Harrow Research Ethics Committee REC 06/Q0408/10
Health condition(s) or problem(s) studiedDigestive System: Ulcerative colitis
InterventionCategorical 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 typeOther
Primary outcome measureThe 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 measuresAdded 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 study start date01/03/2006
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants110 patients will be needed for each group, 220 in total
Key inclusion criteria1. Patients with longstanding extensive colitis, with evidence of microscopic inflammation at a previous colonoscopy
2. Patients over 18
Key exclusion criteriaPre-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
Date of first enrolment01/03/2006
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Wolfson Unit 2nd Floor
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications case report 01/10/2006 Yes No
Results article results 01/06/2012 Yes No

Editorial Notes

14/09/2017: Publication reference added.