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In nonrandomized trials, photodynamic therapy (PDT) had a promising effect on nonresectable cholangiocarcinoma (NCC). A new prospective, open-label, randomized, multicenter study with a group sequential design compared PDT in addition to stenting (group A) with stenting alone (group B) in patients with NCC. PDT resulted in prolongation of survival (group A: n = 20, median 493 days; group B: n = 19, median 98 days; P < 0.0001). It also improved biliary drainage and quality of life. The results led the Authors to conclude that PDT, given in addition to best supportive care, improves survival in patients with NCC. The study was even terminated prematurely because PDT proved to be so superior to simple stenting treatment that further randomization was deemed unethical. Reach the paper through: Gastroenterology 125(5):1355-1363, November 2003. |