Gallstone lithotripsy (GSL): results of the Technomed Sonolith 3000 multicenter trials.

Abstract

Gallstone lithotripsy (GSL) with the Technomed Sonolith 3000 extracorporeal lithotripter was studied in a multisite, international cooperative trial involving the United States, France, and Italy. All participating sites worked under a common protocol to investigate the safety and efficacy of GSL for symptomatic gallstone patients. These collective results are from a mix of 25 academic and community hospital sites using fixed and transportable/mobile versions of the lithotripter. As of November 1, 1990, 661 patients have been treated in this two-arm randomized study (GSL Only vs GSL + Ursodiol [Actigall]). Patients were treated with up to 2,500 shocks per session and only two treatments were allowed. All machines had standardized pressure settings (850 bar nominal) and operator adjustment of output voltage was not allowed. We saw no statistically significantly different results in initial fragmentation between patients pre-loaded with ursodiol for 2 weeks and those treated by GSL alone. Gallbladder clearance rates did vary with the stone number, size, and burden as well as the adequacy of initial fragmentation. In the GSL + Ursodiol Arm of the trial, 46.2% of patients with solitary, 5-to 20-mm calculi are stone-free at 6 months.