Prospective multicenter evaluation of a disposable lithotripter

The Olympus lithotripter has become the standard reusable lithotripter in our participating institutions. Published data has noted a failure rate of 8% due to deployment, capture, and other technical problems. A new disposable device (Boston Scientific Corporation) with preassembled pistol grip handle function may facilitale operation. AIM: To prospectively evaluate the cost, technical performance, and procedure time of a disposable lithotripter. METHODS: 20 pts with common bile duct (CBD) stones were enrolled. Data included device costs, stone size, number of stones, CBD size and configuration (normal, sigmoid or stricture), ease and number of cannulations, basket function (deployment; deployed shape), stone capture and crushing success, procedure time, and complications. The Olympus device was used in failed cases. RESULTS: The disposable lithotripter cost $333 per procedure and the reusable device $625. Maximum stone size averaged 16.5±1.2 mm (range 10-30 mm). 16 pts had multiple stones (median 5, range 2-12). Mean CBD diameter was 20.5±1.5 mm (range 12-38mm). CBD cannulation was successful in all within 5 attempts. Basket deployment failed in 1 pt due to stone size and was misshapen in 14. Stone capture, fragmentation, and clearance were ultimately successful in 16 pts (80%). 2 pts required 2 disposable lithotripters. CBD clearance was incomplete with the lithotripsy basket in 2 pts. Abnormal CBD configuration was noted in 2 out of 4 pts with failed capture and 7 out of 16 with successful clearance. No statistically significant difference between the CBD size, stone size, number of stones, and successful clearance was observed. Average procedure time was 90.519.6 min (n=16) with the disposable lithotripter and 105.3±21.2 (n=4) with the reusable device. One patient developed a delayed sphincterotomy bleed and in one case there was damage to the endoscope elevator. CONCLUSIONS: 1. The success rate of stone capture and disruption with the disposable lithotripter (80%) was less than the published data with the Olympus device (96%). 2. Overall, the disposable device costs substantially less. 3. Basket deployment was less than ideal in most cases. 4. Failure of stone capture and disruption was often associated with abnormal CBD configuration. 5. Procedure times between the disposable and reusable lithotripter were comparable.