A prospective uncontrolled multicenter trial was performed on 113 patients with bile duct stones in whom routine endoscopic approaches for removal of the calculi had failed. These represented 8.3% of the patients referred to the participating centers for endoscopic extraction of the stones. Extracorporeal shock-wave lithotripsy using the Dornier kidney lithotripter achieved stone disintegration in 103 patients (91%). Complete stone clearance from the bile ducts was obtained in 97 patients (86%) after a median of 4 days following extracorporeal shock-wave lithotripsy. Adverse effects, mostly mild, occurred in 36% of the patients. A 30-day mortality rate of 0.9% (in-hospital mortality rate = 1.8%) of this high-risk group with a mean age of 72 yr and a cholangitis rate of 26% compared favorably with the data given for open surgery. We therefore consider extracorporeal shock-wave lithotripsy a useful method for the treatment of bile duct stones not amenable to routine endoscopic measures.