A randomised controlled trial to study the side effect profile and to establish measures of efficacy using photofrin or 5-aminolaevulinic acid (ALA) photodynamic therapy in the eradication of dysplasia in Barretts columnar lined oesophagus
| ISRCTN | ISRCTN16444200 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16444200 |
| Protocol serial number | Version 3.1 |
| Sponsor | University College London (UK) |
| Funder | National Medical Laser Centre (UK) |
- Submission date
- 26/01/2006
- Registration date
- 07/02/2006
- Last edited
- 28/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Laurence Lovat
Scientific
Scientific
National Medical Laser Centre
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
| med.laser@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine whether photodynamic therapy for high grade dysplasia in Barrett's oesophagus using aminolaevulinic acid has less side effects than photofrin. To develop novel measures of efficacy. |
| Ethics approval(s) | Berkshire Research Ethics Committee, 13/01/2006, ref: 05/Q1602/193 |
| Health condition(s) or problem(s) studied | High grade dysplasia in Barrett's oesophagus |
| Intervention | Photodynamic therapy using 5-aminolaevulinic acid versus photofrin |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aminolaevulinic Photofrin |
| Primary outcome measure(s) |
1. Eradication of high grade dysplasia |
| Key secondary outcome measure(s) |
1. Quality of life outcomes |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 66 |
| Key inclusion criteria | 1. Patients with high grade dysplasia in Barrett's oesophagus but without invasive cancer 2. Aged over 21 |
| Key exclusion criteria | 1. Severe cardiovascular disease 2. Liver cirrhosis or seriously impaired hepatic or renal function 3. Depot antipsychotics 4. Concomitant chemoradiotherapy 5. Pregnancy 6. Porphyria 7. Previous photodynamic therapy |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
National Medical Laser Centre
London
W1W 7EJ
United Kingdom
W1W 7EJ
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 | 01/05/2013 | Yes | No |
