Endoscopic ablation of Barrett's oesophagus: a randomised controlled trial comparing photodynamic therapy (PDT) versus argon beam plasma coagulation (ABPC)

ISRCTN ISRCTN08911000
DOI https://doi.org/10.1186/ISRCTN08911000
Secondary identifying numbers N0059089106
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
13/07/2009
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 Clive Kelty
Scientific

University of Sheffield
Surgery/Anaesthetics
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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(s)South Sheffield research ethics committee (REC) approval received (ref: 00/031)
Health condition(s) or problem(s) studiedBarrett's oesophagus
InterventionCompare ABPC and PDT in the ablation of metaplastic and low grade dysplastic Barrett's oesophagus.
Intervention typeOther
Primary outcome measureTolerability of treatment
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2000
Completion date01/11/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants56
Key inclusion criteria1. Currently in an endoscopic screening programme
2. Aged 18 years or older, either sex
3. Biopsy proven Barrett’s epithelium with a median length of 4 cm
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2000
Date of final enrolment01/11/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Sheffield
Sheffield
S10 2JF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Sheffield Teaching Hospitals NHS Foundation Trust (UK) - Central Campus

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2004 Yes No