Extracorporeal shock-wave cholelithotripsy was carried out in 135 symptomatic patients with radiolucent gallstones, followed by oral bile acid dissolution to assess the resultant stone disappearance rates. Fragmentation was satisfactory (all fragments less than 5 mm in diameter) in 34 patients (25%) after a single session of lithotripsy, and in 65 (48%) after multiple sessions. The overall satisfactory fragmentation rate was significantly higher in patients with single stones less than or equal to 20 mm in diameter when compared with those with larger solitary stones (71% vs. 38%, p less than 0.05), as it also was in all subjects with solitary stones when compared with those with multiple stones (60% vs. 34%, p less than 0.05). After 6, 9, and 12 mo of oral bile acid treatment, the stone-free rates were significantly higher in patients with satisfactory than in those with partial fragmentation (55% vs. 0%, 80% vs. 29%, and 90% vs. 33%, respectively; p less than 0.05). Only 1 of the 7 patients who had previously undergone endoscopic sphincterotomy for concomitant choledocholithiasis was free of stones after 1 yr of dissolution. During dissolution therapy, of the 102 patients in whom fragmentation had occurred, 1 (1%) developed mild acute pancreatitis, 23 (23%) suffered attacks of biliary colic, and 6 (6%) required cholecystectomy. We conclude that the result of fragmentation appears to be a major determinant of the success and rapidity of subsequent oral bile acid dissolution, and that when satisfactory, it allows for complete stone disappearance in most patients within the following year. A comparison of the present results with those of previous original studies suggests that to achieve such satisfactory fragmentation, patients should be selected on the basis of their stone characteristics, which optimally should present as solitary gallbladder calculi less than 20 mm in diameter. Furthermore, real-time ultrasonographic monitoring should be used during lithotripsy with a transducer centered along the shock-wave axis. Despite the innocuousness of the shock waves, the incidence of fragment migration and its possible complications, in our experience, emphasizes the need to restrict at present this nonoperative approach to the treatment of symptomatic gallstone disease.