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 |
| Protocol serial number | N0059089106 |
| Sponsor | Department of Health (UK) |
| Funder | Sheffield Teaching Hospitals NHS Foundation Trust (UK) - Central Campus |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Tolerability of treatment |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Sheffield
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
