Twenty studies were included in the review (n=829 participants, 342 of whom received photodynamic therapy). There were two RCTs, two controlled trials, one comparative study with historical controls and 15 case studies. Sample sizes ranged from one to 184 (mean 27). Study quality was low or moderate; most studies were uncontrolled pre-post designs.
One RCT found a prolongation of survival (493 days versus 98 days in comparison group); a second RCT not only found increased median survival (21 versus seven months) but also reported a substantial incidence of post-procedural cholangitis. Three other comparative studies reported substantial increases in median survival in the photodynamic therapy compared to the comparison groups.
The most common adverse events were cholangitis (27.5%), phototoxicity (10.2%) and biloma (1.8%); other adverse events reported (incidence below 1% in all cases) were choleocystitis, sepsis, pulmonary embolism, pancreatitis, abscess, stenosis, bleeding and biliary leakage.