Condition category
Digestive System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

1. 2006 case report in http://www.ncbi.nlm.nih.gov/pubmed/16966701

Publication citations

  1. 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.

Additional files

Editorial Notes