Extracorporeal shock wave lithotripsy (ESWL) has been used since 1985 in a variety of countries for the treatment of gallstones in selected patients (1–14). Clinical use has been routine in western Europe for a decade (15). The limited experience in the United States has been investigational, through tests of the Medstone STS lithotripter (Medstone International, Aliso Viejo, CA) (2, 10, 11), EDAP LT01 lithotripter (EDAP Technomed, Boston, MA) (5), and Dornier lithotripter (Dornier Medical Systems, Munich, Germany) (6). ESWL of cholesterol gallstones with adjuvant bile acid dissolution therapy accelerates stone disappearance; ESWL shatters the stone into small fragments that can be dissolved more quickly. Analysis of stone fragments in the feces of patients who underwent ESWL showed that 3-mm fragments can pass into the intestine without causing symptoms (16). In September, 2000 the Food and Drug Administration approved, subject to a postapproval study, the first lithotripter for gallstone application in the United States, the Medstone STS. Treatment, which comprises lithotripsy treatments of up to 2000 24-kV shocks and administration of ursodiol, is indicated in symptomatic adult patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery. Patients must have functioning gallbladders and solitary, radiolucent, noncalcified stones from 4 to 20 mm in maximum diameter. Ursodiol is a naturally occurring bile acid that dissolves gallstones of cholesterol origin. Lithotripters vary with respect to shock wave generation, focusing, and targeting. The Medstone STS, which has been commercially available for the treatment of kidney stones in the United States since 1988, generates a spark-gap shock wave in a water column. The shock wave pulse travels with little attenuation through the water column and soft tissues of the body. When it hits the anterior surface of the gallstone throughout the posterior surface, the changes in acoustic impedance lead to the liberation of compressive and tensile forces, resulting in fragmentation of the stone. Other devices use this electrohydraulic approach or piezoelectric crystals or electromagnetic membranes to generate the shock waves. The multicenter, prospective, postapproval randomized trial of the Medstone STS lithotripter in gallstone therapy is directed toward confirmation of efficacy and collection of additional data supporting safety in routine clinical practice. The selected patients will be treated in the prone position, using i.v. propofol analgesia, and on an outpatient basis. Efficacy of ESWL will be defined as the percentage of patients with stone-free gallbladders according to abdominal ultrasound after 3, 6, and 12 months. Findings will be compared with the results of ursodiol monotherapy.
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