Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study.
OBJECTIVE
In nonrandomized trials, photodynamic therapy (PDT) had a promising effect on nonresectable cholangiocarcinoma (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 patients with NCC.


METHODS
In patients with histologically confirmed cholangiocarcinoma, endoscopic or percutaneous double stenting was performed. Patients fulfilling inclusion criteria were randomized to group A (stenting and subsequent PDT) and group B (stenting alone). For PDT, Photofrin 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 residual tumor in the bile duct. The primary outcome parameter was survival time. Secondary outcome parameters were cholestasis 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 patients with NCC. The study was terminated prematurely because PDT proved to be so superior to simple stenting treatment that further randomization was deemed unethical.
Ortner
Marianne E J
ME
Division de Gastro-entérologie et Hépatologie, BH-10N, Centre Hospitalier Universitaire Vaudois, CH-1011 CHUV-Lausanne, Switzerland. Maria-Anna.Ortner@hospvd.ch
Caca
Karel
K
Berr
Frieder
F
Liebetruth
Jochen
J
Mansmann
Ulrich
U
Huster
Dominik
D
Voderholzer
Winfried
W
Schachschal
Guido
G
Mössner
Joachim
J
Lochs
Herbert
H
D001650:Bile Duct Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000628:therapy; D018281:Cholangiocarcinoma / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000628:therapy; D017323:Dihematoporphyrin Ether / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004724:Endoscopy; D006801:Humans; D007275:Injections, Intravenous; D008403:Mass Screening; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D015607:Stents; D016019:Survival Analysis
D017319:Photosensitizing Agents; D017323:Dihematoporphyrin Ether