Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial

Tim Large, Charles Nottingham, Ethan Brinkman, Deepak Agarwal, Andrea Ferrero, Michael Sourial, Karen Stern, Marcelino Rivera, Bodo Knudsen, Mitchel Humphreys, Amy Krambeck, Tim Large, Charles Nottingham, Ethan Brinkman, Deepak Agarwal, Andrea Ferrero, Michael Sourial, Karen Stern, Marcelino Rivera, Bodo Knudsen, Mitchel Humphreys, Amy Krambeck

Abstract

Introduction: Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters: Trilogy and ShockPulse-SE. Materials and Methods: This is a prospective multi-institutional randomized trial comparing outcomes of PCNL using two novel lithotripters between February 2019 and June 2020. The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications. Device assessment was provided through immediate postoperative survey by primary surgeons. Results: There were 100 standard PCNLs completed using either a Trilogy or ShockPulse-SE lithotrite. Using quantitative Stone Analysis Software to estimate stone volume, the mean stone volume was calculated at 4.18 ± 4.79 and 3.86 ± 3.43 cm3 for the Trilogy and ShockPulse-SE groups, respectively. Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm3/min for Trilogy vs ShockPulse-SE (p = 0.0542). When comparing Trilogy to ShockPulse-SE in a multivariate analysis, total operative room time (104.4 ± 48.2 minutes vs 121.1 ± 59.2 minutes p = 0.126), rates of secondary procedures (17.65% vs 40.81%, p = 0.005), and device malfunctions (1.96% vs 34.69%, p < 0.001) were less, respectively. There was no difference in final stone-free rates between devices. Conclusion: Both the Trilogy and ShockPulse-SE lithotripters are highly efficient at removing large renal stones. In this study, we noted differences between the two devices including fewer device malfunctions when Trilogy device was utilized. Clinical Trial ID number: NCT03959683.

Keywords: lithotripter; nephrolithiasis; percutaneous nephrolithotomy.

Conflict of interest statement

Dr. Amy Krambeck is a consultant for Boston Scientific Corporation, Lumenis, and Sonomotion. Dr. Mitchell Humphreys is a consultant for Boston Scientific Corporation and AURIS, Dr. Bodo Knudsen is a consultant for Boston Scientific Corporation, Olympus Surgical, and Becton Dickinson and Company. Dr. Marcelino Rivera and Dr. Tim Large are consultants for Boston Scientific Corporation.

Figures

FIG. 1.
FIG. 1.
Graphical representation of stone volume (cm3) and clearance time (minutes) partitioned by lithotripter type.

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