TY - JOUR
T1 - Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters
T2 - ShockPulse-SE vs Trilogy Trial
AU - Large, Tim
AU - Nottingham, Charles
AU - Brinkman, Ethan
AU - Agarwal, Deepak
AU - Ferrero, Andrea
AU - Sourial, Michael
AU - Stern, Karen
AU - Rivera, Marcelino
AU - Knudsen, Bodo
AU - Humphreys, Mitchel
AU - Krambeck, Amy
N1 - Funding Information:
This study was supported by grant no. 072612-00001A from Boston Scientific.
Publisher Copyright:
© Tim Large et al., 2021; Published by Mary Ann Liebert, Inc. 2021.
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - lithotripter
KW - nephrolithiasis
KW - percutaneous nephrolithotomy
UR - http://www.scopus.com/inward/record.url?scp=85115235610&partnerID=8YFLogxK
U2 - 10.1089/end.2020.1097
DO - 10.1089/end.2020.1097
M3 - Article
C2 - 33843245
AN - SCOPUS:85115235610
SN - 0892-7790
VL - 35
SP - 1326
EP - 1332
JO - Journal of Endourology
JF - Journal of Endourology
IS - 9
ER -