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Objective: To investigate the role of extracorporeal shock wave lithotripsy using the Dornier MPL9000 lithotripter and adjuvant litholytic therapy in the treatment of symptomatic gallbladder stones., Patients and Methods: Between August 1989 and March 1991, 399 patients had their one to three gallbladder stones fragmented by the Dornier MPL9000 lithotripter. Chenodeoxycholic acid alone was used as adjuvant litholytic therapy in the majority. A minority received a combination of chenodeoxycholic acid and ursodeoxycholic acid or ursodeoxycholic acid alone. Patients who died, had cholecystectomies or failed to complete the treatment program were excluded from analysis, leaving a cohort of 287 patients with a follow-up of at least 12 months. This cohort comprised 173 patients with single small stones (20 mm or less in diameter), 32 patients with single large stones (21 mm to 30 mm in diameter) and 82 patients with two to three stones., Outcome Measures: Patients were followed up by repeated ultrasound examination to monitor the disappearance of fragments from the gallbladder. Stone-free rates, recurrences and complications of treatment were determined., Results: The stone-free rate 12 months after treatment was 37.6% for patients with a single small stone, 3.1% for patients with a single large stone and 18.3% for patients with two to three stones. Of 70 patients with a single small stone who had become stone free at some time during the 12 months after treatment, five (7.1%) experienced recurrence, as did one of the 16 patients (6.9%) with two to three stones. Some 179 patients (44.9%) experienced biliary colic after lithotripsy. Most attacks were mild. Eleven patients (2.8%) developed cholecystitis and nine (2.3%) became jaundiced. Five patients (1.3%) suffered from pancreatitis, of whom one died from severe necrotising pancreatitis. Treatment mortality was 0.25%. Cholecystectomy was needed in 44 patients (11.9%)., Conclusions: Only about 15%-20% of all patients with symptomatic gallbladder stones are suitable for lithotripsy. In this study, only about 28% were stone free after 12 months. As the gallbladder is not removed, stones may re-form. Laparoscopic cholecystectomy and open cholecystectomy by comparison will produce a "stone-free state" in 100% of patients, no matter how many stones are present in the gallbladder, their size, or whether the gallbladder is non-functioning. Consequently, lithotripsy and litholytic therapy are now reserved for those few patients who are unable to tolerate general anaesthesia and cholecystectomy and those who refuse surgery. Even in centres showing the most favourable results, lithotripsy and litholytic therapy will have at best a minor role to play in the overall management of symptomatic gallbladder stones.