Photodynamic therapy for dysplastic Barrett's oesophagus: a prospective, double blind, randomised, placebo controlled trial

Background and aims-Photodynamic therapy (PDT) is a treatment in which cell damage is achieved by the action of Light on a photosensitising agent. We have assessed the potential use of PDT in the ablation of Barrett's oesopha gus. Methods-Thirty six patients with dysplastic Barrett's oesophagus receiving acid suppression medication with omeprazole were randomised to receive oral 5-aminolaevulinic acid (ALA) 30 mg/kg or placebo, followed four hours late r by laser endoscopy. Follow up endoscopy was performed at one, six, 12, an d 24 months. Results-Of 18 patients in the ALA group, a response was seen in 16 (median decrease in area in the treated region 30%; range 0-60%). In the placebo gr oup, a decrease in area of 10% was observed in two patients with no change in 16 (median 0%; range 0-10%; treatment v placebo, p<0.001). No dysplasia was seen in the columnar epithelium within the treatment area of any patien t in the PDT group. However, in the placebo group, persistent low grade dys plasia was found in 12 patients (p<0.001). There were no short or long term major side effects. The effects of treatment were maintained far up to 24 months. Conclusions-This is the first randomised controlled trial of PDT for Barret t's oesophagus. It demonstrates that ALA induced PDT can provide safe and e ffective ablation of low grade dysplastic epithelium.