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
Scientific
University of Sheffield
Surgery/Anaesthetics
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | South Sheffield research ethics committee (REC) approval received (ref: 00/031) |
| Health condition(s) or problem(s) studied | Barrett's oesophagus |
| Intervention | Compare ABPC and PDT in the ablation of metaplastic and low grade dysplastic Barrett's oesophagus. |
| Intervention type | Other |
| Primary outcome measure | Tolerability of treatment |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2000 |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 56 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Sheffield
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
