Gallstone lithotripsy: early American results and the new reality

Early comparative data is now available from several different American Gallstone Lithotripsy, ("GSL") trials (Technomed, Dornier, and Medstone). While the 6-month gallbladder clearance results appear to be remarkably similar (36%-43% in less than 20-mm solitary stones), they do not appear to match the results obtained by the Munich group in their first 175 patients (63% clearance at 4-8 months). We review the currently available American data and describe our on-going national clinical trial with the Technomed Sonolith 3000 investigation. In this trial, patients are randomized to lithotripsy plus ursodiol (Actigall,¿ Ciba Geigy), or lithotripsy alone to determine the effect of oral bile salts on the gallbladder fragment clearance rate. To date, the early success rate is clearly better in the GSL plus ursodiol arm. Following one or two lithotripsy sessions, 62.1% of patients with solitary stones, 5-20 mm in size, have had fragmentation to 7 mm or less. In the same group, 39.1% of gallbladders are clear at 6 months. While the 6-month gallbladder clearance rate appears to be a reliable indicator of eventual gallbladder status it should not be regarded as the end point of therapy and it clearly does not represent the final efficacy rate for gallstone lithotripsy. A review of the results obtained from on-going American IDE trials is compared with the published German results using GSL and combination oral dissolution therapy.