The use of aminolaevulinic acid (ALA) and photodynamic therapy (PDT) in the treatment of Barrett's oesophagus
| ISRCTN | ISRCTN05257682 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05257682 |
| Protocol serial number | 940129 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 12/12/2013
- 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
Prof M W Reed
Scientific
Scientific
Department of Surgery and Anaesthetics
Floor K
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)114 271 2163/3167 |
|---|---|
| mw.reed@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Barrett's oesophagus is an acquired condition due to long-standing acid reflux which destroys the normal oesophageal lining. This is replaced by a lining which carries a significant risk of malignant change. Current therapeutic approaches aim to reduce oesophageal exposure to refluxing stomach contents either by medical or surgical means, but this may not prevent the development of cancer. Alternate forms of therapy are therefore required. PDT is a new form of cancer treatment in which cell damage is achieved by the action of laser light of specific wavelength upon a light sensitive drug which is taken up by malignant or pre-malignant tissue. This results in targeting of the treatment to the tumour and limits normal tissue damage. The clinical use of PDT has been restricted by the side effects of the light sensitive drugs. A new agent, ALA with few side effects has been successfully used in the treatment of skin and bladder cancer. The aim of the study is to evaluate the use of PDT using ALA and green light delivered from a copper vapour laser in the treatment of Barrett's oesophagus. The researchers also aim to quantify and characterise tissue porphyrin levels from biopsy samples, which has not previously been done in this condition. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Barrett's oesophagus |
| Intervention | Patients will be randomised either to a treatment group (receiving treatment as above) or a control group (where the treatment will be identical except that no ALA will be added to the carrier medium). The clinician and the patient will be blinded to the group to which individuals are allocated. As gastric acid suppression with omeprazole has been shown to have a partial effect in reversing Barrett's oesophagus and reduced exposure to acid may encourage re-epithelialisation with normal squamous mucosa, all patients will receive omeprazole. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aminolaevulinic acid |
| Primary outcome measure(s) |
Ablation of low grade dysplastic epithelium |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with biopsy proven high grade dysplasia associated with Barrett's oesophagus who would otherwise require oesophagogastrectomy will be offered ALA-induced PDT. Two groups: 1. Patients with high grade dysplasia who will receive PDT followed by surgery if there is no response 2. Patients with low grade dysplasia who are at lower risk of carcinoma will be entered into a controlled trial and followed up by endoscopy to assess the efficacy and duration of any treatment effects. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/1995 |
| Date of final enrolment | 31/03/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Surgery and Anaesthetics
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 | 01/11/2000 | Yes | No |
