Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0059089106
Study information
Scientific title
Acronym
Study hypothesis
To compare argon beam plasma coagulation (ABPC) and photodynamic therapy (PDT) in the ablation of metaplastic and low grade dysplastic Barrett's oesophagus, in a randomised controlled prospective clinical trial.
Ethics approval
South Sheffield research ethics committee (REC) approval received (ref: 00/031)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Barrett's oesophagus
Intervention
Compare ABPC and PDT in the ablation of metaplastic and low grade dysplastic Barrett's oesophagus.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Tolerability of treatment
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2000
Overall trial end date
01/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Currently in an endoscopic screening programme
2. Aged 18 years or older, either sex
3. Biopsy proven Barretts epithelium with a median length of 4 cm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2000
Recruitment end date
01/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
Sheffield
S10 2JF
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
Sheffield Teaching Hospitals NHS Foundation Trust (UK) - Central Campus
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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15606390
Publication citations
-
Results
Kelty CJ, Ackroyd R, Brown NJ, Stephenson TJ, Stoddard CJ, Reed MW, Endoscopic ablation of Barrett's oesophagus: a randomized-controlled trial of photodynamic therapy vs. argon plasma coagulation., Aliment. Pharmacol. Ther., 2004, 20, 11-12, 1289-1296, doi: 10.1111/j.1365-2036.2004.02277.x.