Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/11034574

Publication citations

  1. 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.

Additional files

Editorial Notes