Clinical application of a new disposable lithotripter: a prospective multicenter study

Background: Mechanical lithotripsy has become a well-accepted method of bil e duct stone fragmentation and removal. The Olympus lithotripter (Olympus A merican, Melville, NY) is the standard reusable lithotripter at the institu tions that participated in this study. A disposable device with a preassemb led pistol grip may perform equally well and facilitate operation. Methods: Twenty patients with bile duct stones were evaluated as part of a multicenter prospective study. Data were obtained regarding stone size and number, bile duct diameter, and configuration, ease of cannulation, basket function, stone capture and crushing success, and complications. Results: The maximum stone size averaged 16.5 +/- 1.2 mm (range 10 to 30 mm ). Sixteen patients had multiple stones (median 5, range 2 to 12). The mean bile duct diameter was 20.5 +/- 1.5 mm (range 12 to 38 mm). Cannulation wa s successful in all within 5 attempts. Basket deployment failed in 1 patien t because of stone size and the basket was misshapen in 14. Bile duct clear ance was complete in 16 subjects (80%), incomplete in 2 patients, and faile d in 2 patients. Abnormal duct configuration (sigmoid, stricture) was noted in 2 of 4 patients with failed capture and 7 of 16 patients with successfu l clearance. No statistically significant difference was observed between t he bile duct diameter, maximum stone size, number of stones, and successful clearance. Conclusion: The disposable lithotripter is easy to use and, compared with t he published results for the reusable lithotripter, performs almost as well .