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
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 |
|---|---|
| b.saunders@imperial.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format; for printed version please contact the investigators at the address below |
| 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 | 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 study start date | 01/03/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 110 patients will be needed for each group, 220 in total |
| 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
- England
- United Kingdom
Study participating centre
The Wolfson Unit 2nd Floor
Harrow
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
