The use of methylene blue dye in the diagnosis of dysplasia in Barrett's Oesophagus Surveillance
| ISRCTN | ISRCTN15254497 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15254497 |
| Secondary identifying numbers | N0436121390 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 12/02/2010
- 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 CH Lim
Scientific
Scientific
Room 190A, Gastroenterology Department
Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The purpose of this study is to compare the use of MB directed biopsies (MBDB) to random biopsies (RB) in the diagnosis of dysplasia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Dysplasia |
| Intervention | 1. Methylene blue directed biopsies 2. Random biopsies |
| Intervention type | Other |
| Primary outcome measure | The frequency of dysplasia between methylene blue directed biopsies and random biopsies. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Barrett's oesophagus patients with recent diagnosis of dysplasia |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Room 190A, Gastroenterology Department
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Leeds Teaching 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? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2006 | Yes | No |
