Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
13/07/2009
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 Clive Kelty

ORCID ID

Contact details

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

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 measures

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

Eligibility

Participant inclusion criteria

1. 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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15606390

Publication citations

  1. 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.

Additional files

Editorial Notes