Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
02/10/2014
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 (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

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22958651

Publication citations

  1. 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.

Additional files

Editorial Notes