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 |
| Protocol serial number | N0436121390 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The frequency of dysplasia between methylene blue directed biopsies and random biopsies. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Room 190A, Gastroenterology Department
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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 | 01/08/2006 | Yes | No |
