Treatment of gallstones with piezoelectric lithotripsy and oral bile acids. A multicenter study.

The efficacy of the combination of piezoelectric lithotripsy and oral bile acids in the treatment of gallbladder stones was assessed. Three hundred and sixty-three patients with symptomatic radiolucent gallstones in functioning gallbladder were treated in five medical centers using the same protocol with the EDAP LT 01 lithotripter. No anesthesia, analgesia or sedation was used. After one session of lithotripsy, fragmentation was observed in 89% of the patients, and satisfactory fragmentation (fragments less than or equal to 5 mm) in 29%. The satisfactory fragmentation rate was higher in patients with solitary stones less than or equal to 20 mm than in patients with solitary stones 21-35 mm or multiple stones (p less than 0.001). After multiple sessions (mean 1.6 session/patient, range 1-5) the overall rate of satisfactory fragmentation was 50%. After 12 months on oral bile acid therapy, complete clearance of the gallbladder was observed in 69% of patients with solitary stones less than or equal to 20 mm, 25% of patients with solitary stones 21-35 mm and 37% of patients with multiple stones. No complication was observed during the lithotripsy. During follow-up under bile acid therapy, there were five complications (1.4%): four patients had acute cholecystitis and one had mild, self-limited pancreatitis. We conclude that piezoelectric lithotripsy with the EDAP lithotripter is a safe and effective treatment which can be performed in outpatients. Satisfactory fragmentation and rapid disappearance of stones are obtained mainly in patients with solitary stones less than or equal to 20 mm.