Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
, 66 (3), 460-8

Five-year Efficacy and Safety of Photodynamic Therapy With Photofrin in Barrett's High-Grade Dysplasia

Clinical Trial

Five-year Efficacy and Safety of Photodynamic Therapy With Photofrin in Barrett's High-Grade Dysplasia

Bergein F Overholt et al. Gastrointest Endosc.


Background: Barrett's esophagus (BE) with high-grade dysplasia (HGD) is a risk factor for development of esophageal carcinoma. Photodynamic therapy (PDT) with Photofrin (PHO) has been used to eliminate HGD in BE.

Objective: Our purpose was to compare PHOPDT plus omeprazole with omeprazole only (OM).

Design: Five-year follow-up of a randomized, multicenter, multinational, pathology-blinded HGD trial.

Setting: 30 sites in 4 countries.

Patients: 208.

Interventions: Patients with BE and HGD were randomized (2:1) to PHOPDT (n=138) or OM (n=70) into a 2-year trial followed up for 3 more years. PHOPDT patients received 2 mg/kg PHO intravenously followed by endoscopic laser light exposure of Barrett's mucosa at a wavelength of 630 nm within 40 to 50 hours to a maximum of 3 courses at least 90 days apart. Both groups received 20 mg of OM twice daily. Pathologists at one center assessed biopsy specimens in a blinded fashion.

Main outcome measurement: HGD ablation status over 5 years of follow-up.

Results: At 5 years PHOPDT was significantly more effective than OM in eliminating HGD (77% [106/138] vs 39% [27/70], P<.0001). A secondary outcome measure preventing progression to cancer showed a significant difference (P=.027) with about half the likelihood of cancer occurring in PHOPDT (21/138 [15%]) compared with OM (20/70 [29%]), with a significantly (P=.004) longer time to progression to cancer favoring PHOPDT.

Limitations: Not all patients were available for follow-up.

Conclusions: This 5-year randomized trial of BE patients with HGD demonstrates that PHOPDT is a clinically and statistically effective therapy in producing long-term ablation of HGD and reducing the potential impact of cancer compared with OM.

Comment in

Similar articles

See all similar articles

Cited by 95 PubMed Central articles

See all "Cited by" articles

Publication types

MeSH terms

LinkOut - more resources