Successful photodynamic therapy for nonresectable XXXX : a randomized prospective study.

@entity1 @entity17654 @entity41 @entity1448 @entity201
BACKGROUND _ AIMS: In nonrandomized trials, photodynamic therapy (PDT) had a promising effect on nonresectable @entity201 (NCC). This 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 @entity1 with NCC. METHODS: In @entity1 with histologically confirmed @entity201 , endoscopic or percutaneous double stenting was performed. @entity1 fulfilling inclusion criteria were randomized to group A (stenting and subsequent PDT) and group B (stenting alone). For PDT, @entity17654 2 mg/kg body wt was injected intravenously 2 days before intraluminal photoactivation (wavelength, 630 nm; light dose, 180 J/cm(2)). Further treatments were performed in cases of @entity41 in the bile duct. The primary outcome parameter was survival time. Secondary outcome parameters were @entity1448 and quality of life. RESULTS: 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. CONCLUSIONS: PDT, given in addition to best supportive care, improves survival in @entity1 with NCC. The study was terminated prematurely because PDT proved to be so superior to simple stenting treatment that further randomization was deemed unethical.
