Contact information
Type
Scientific
Primary contact
Prof M W Reed
ORCID ID
Contact details
Department of Surgery and Anaesthetics
Floor K
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
+44 (0)114 271 2163/3167
mw.reed@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
940129
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Aminolaevulinic acid
Primary outcome measure
Ablation of low grade dysplastic epithelium
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1995
Overall trial end date
31/03/1996
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1995
Recruitment end date
31/03/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery and Anaesthetics
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/11034574
Publication citations
-
Results
Ackroyd R, Brown NJ, Davis MF, Stephenson TJ, Marcus SL, Stoddard CJ, Johnson AG, Reed MW, Photodynamic therapy for dysplastic Barrett's oesophagus: a prospective, double blind, randomised, placebo controlled trial., Gut, 2000, 47, 5, 612-617.