OBJECTIVE: The primary goal of this study was to investigate whether oral steroids would reduce the incidence of stricture formation after photodynamic therapy (PDT) in Barrett's patients. The effect of balloon window length, pretreatment of nodules, retreatment of skipped areas, and subsequent PDT on the incidence of strictures was also investigated. The ultimate goal of treatment was elimination of dysplasia, early cancer, and Barrett's mucosa. METHODS: A total of 60 patients were injected with Photofrin (2 mg/kg). Patients were randomized to receive PDT (n = 30) or PDT and oral prednisone (n = 30). Two days later, 630 nm light (KTP/dye laser) was delivered using a 5- or 7-cm windowed balloon at a light dose of 200 or 175 J/cm. The majority of patients received 200 J/cm using a 7-cm balloon. Nodules were pretreated with a short diffuser at a dose of 50-75 J/cm. Additional light was delivered to skipped areas 2-3 days later. Endoscopies were conducted every 3-6 months to evaluate the response. Residual or recurrent Barrett's was treated using neodymium:aluminum-yttrium-garnet (Nd:YAG) laser (small areas) or was retreated with PDT. RESULTS: The effect of steroids on the incidence of strictures was analyzed in patients receiving a single treatment with a light dose of 200 J/cm using a 7- cm balloon. There was no reduction in the incidence of strictures in patients receiving PDT and steroids (29%) compared to those receiving PDT alone (16%). Treatment using a 7-cm balloon caused more strictures (31%) than treatments using a 5-cm balloon (7%). Pretreatment of nodules or retreatment of skipped areas did not increase strictures. Patients receiving subsequent PDT had a higher incidence of strictures. Cancer was eliminated in all patients. High-grade dysplasia was eliminated in 41 of 43 patients (96%). Barrett's mucosa was totally eliminated in 25 of 60 patients (42%). CONCLUSIONS:Oral prednisone after PDT did not reduce the incidence of strictures. Subsequent PDT and longer balloon window were associated with higher incidence of strictures. PDT followed by thermal ablation of small islands eliminated dysplasia, early cancer, and Barrett's mucosa.
RCT Entities:
OBJECTIVE: The primary goal of this study was to investigate whether oral steroids would reduce the incidence of stricture formation after photodynamic therapy (PDT) in Barrett's patients. The effect of balloon window length, pretreatment of nodules, retreatment of skipped areas, and subsequent PDT on the incidence of strictures was also investigated. The ultimate goal of treatment was elimination of dysplasia, early cancer, and Barrett's mucosa. METHODS: A total of 60 patients were injected with Photofrin (2 mg/kg). Patients were randomized to receive PDT (n = 30) or PDT and oral prednisone (n = 30). Two days later, 630 nm light (KTP/dye laser) was delivered using a 5- or 7-cm windowed balloon at a light dose of 200 or 175 J/cm. The majority of patients received 200 J/cm using a 7-cm balloon. Nodules were pretreated with a short diffuser at a dose of 50-75 J/cm. Additional light was delivered to skipped areas 2-3 days later. Endoscopies were conducted every 3-6 months to evaluate the response. Residual or recurrent Barrett's was treated using neodymium:aluminum-yttrium-garnet (Nd:YAG) laser (small areas) or was retreated with PDT. RESULTS: The effect of steroids on the incidence of strictures was analyzed in patients receiving a single treatment with a light dose of 200 J/cm using a 7- cm balloon. There was no reduction in the incidence of strictures in patients receiving PDT and steroids (29%) compared to those receiving PDT alone (16%). Treatment using a 7-cm balloon caused more strictures (31%) than treatments using a 5-cm balloon (7%). Pretreatment of nodules or retreatment of skipped areas did not increase strictures. Patients receiving subsequent PDT had a higher incidence of strictures. Cancer was eliminated in all patients. High-grade dysplasia was eliminated in 41 of 43 patients (96%). Barrett's mucosa was totally eliminated in 25 of 60 patients (42%). CONCLUSIONS: Oral prednisone after PDT did not reduce the incidence of strictures. Subsequent PDT and longer balloon window were associated with higher incidence of strictures. PDT followed by thermal ablation of small islands eliminated dysplasia, early cancer, and Barrett's mucosa.
Authors: Melina C Vassiliou; Daniel von Renteln; Daniel C Wiener; Stuart R Gordon; Richard I Rothstein Journal: Surg Endosc Date: 2009-08-27 Impact factor: 4.584