Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436121390
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Digestive System: Dysplasia
Intervention
1. Methylene blue directed biopsies
2. Random biopsies
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The frequency of dysplasia between methylene blue directed biopsies and random biopsies.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Barrett's oesophagus patients with recent diagnosis of dysplasia
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Room 190A, Gastroenterology Department
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching 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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16860068
Publication citations
-
Results
Lim CH, Rotimi O, Dexter SP, Axon AT, Randomized crossover study that used methylene blue or random 4-quadrant biopsy for the diagnosis of dysplasia in Barrett's esophagus., Gastrointest. Endosc., 2006, 64, 2, 195-199, doi: 10.1016/j.gie.2005.07.025.