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
Protocol serial number	N0515176147
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	North West London Hospitals NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of Narrow Band imaging with magnification (NBI) versus white light endoscopy for dysplasia detection in ulcerative colitis surveillance
Study objectives	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(s)	Added 17 July 2008: approval granted by Harrow Research Ethics Committee REC 06/Q0408/10
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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?
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	220
Key inclusion criteria	1. Patients with longstanding extensive colitis, with evidence of microscopic inflammation at a previous colonoscopy 2. Patients over 18
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Wolfson Unit 2nd Floor

Harrow
HA1 3UJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No
Other publications	case report	01/10/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/09/2017: Publication reference added.