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
Secondary identifying numbers 940129
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

Department of Surgery and Anaesthetics
Floor K
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Phone +44 (0)114 271 2163/3167
Email mw.reed@sheffield.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesBarrett'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) studiedBarrett's oesophagus
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Aminolaevulinic acid
Primary outcome measureAblation of low grade dysplastic epithelium
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1995
Completion date31/03/1996

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients 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 criteriaNot provided at time of registration
Date of first enrolment01/04/1995
Date of final enrolment31/03/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Surgery and Anaesthetics
Sheffield
S10 2JF
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Trent

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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