Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr CH Lim

ORCID ID

Contact details

Room 190A
Gastroenterology Department
Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes