Randomised controlled trial of narrow band imaging (NBI) versus standard endoscopy for adenoma detection
| ISRCTN | ISRCTN36386665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36386665 |
| Protocol serial number | N0515176146 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Funder | North West London Hospitals NHS Trust (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 02/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
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 (0)20 8235 4225 |
|---|---|
| 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 | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Colonoscopy |
| Intervention | Narrow band imaging (NBI) versus standard endoscopy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 214 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/01/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Wolfson Unit 2nd Floor
Harrow
HA1 3UJ
United Kingdom
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 | 01/11/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
