The Canadian StoneBreaker trial: a randomized, multicenter trial comparing the LMA StoneBreaker™ and the Swiss LithoClast® during percutaneous nephrolithotripsy.

BACKGROUND AND PURPOSE: Percutaneous nephrolithotripsy (PCNL) is the treatment of choice for patients with large renal stones. The StoneBreaker™ (SB) is a novel handheld pneumatic lithotriptor, powered by a compressed carbon dioxide cartridge. The purpose of this study was to compare the efficiency of the SB to a standard pneumatic lithotriptor, the Swiss LithoClast(®) (LC).

PATIENTS AND METHODS: From January 2008 to December 2009, patients undergoing PCNL were randomized to either the SB or the Swiss LC. Primary outcomes included time to fragment the stone, retrieve the fragments, and remove debris using ultrasonic lithotripsy. Secondary end points were stone-free rate, lithotriptor setup time, ease of use, operator fatigue, endoscopic visualization, damage to mucosa, and device-related complications.

RESULTS: Of the initial 115 patients recruited, 77 were enrolled and 38 were excluded. The SB had significantly faster stone fragmentation time, total lithotripsy time, and setup time than the Swiss LC (P ≤ 0.05). A significant difference was also noted in the ease of use and operator fatigue in favor of the SB. There were no device-related complications.

CONCLUSION: The SB pneumatic lithotriptor is easier to set up and use, and it provides faster stone fragmentation than the Swiss LC.