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

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 rando...

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Autores principales: Large, Tim, Nottingham, Charles, Brinkman, Ethan, Agarwal, Deepak, Ferrero, Andrea, Sourial, Michael, Stern, Karen, Rivera, Marcelino, Knudsen, Bodo, Humphreys, Mitchel, Krambeck, Amy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558064/
https://www.ncbi.nlm.nih.gov/pubmed/33843245
http://dx.doi.org/10.1089/end.2020.1097
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author Large, Tim
Nottingham, Charles
Brinkman, Ethan
Agarwal, Deepak
Ferrero, Andrea
Sourial, Michael
Stern, Karen
Rivera, Marcelino
Knudsen, Bodo
Humphreys, Mitchel
Krambeck, Amy
author_facet Large, Tim
Nottingham, Charles
Brinkman, Ethan
Agarwal, Deepak
Ferrero, Andrea
Sourial, Michael
Stern, Karen
Rivera, Marcelino
Knudsen, Bodo
Humphreys, Mitchel
Krambeck, Amy
author_sort Large, Tim
collection PubMed
description 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 cm(3) for the Trilogy and ShockPulse-SE groups, respectively. Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm(3)/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
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spelling pubmed-85580642021-11-01 Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial Large, Tim Nottingham, Charles Brinkman, Ethan Agarwal, Deepak Ferrero, Andrea Sourial, Michael Stern, Karen Rivera, Marcelino Knudsen, Bodo Humphreys, Mitchel Krambeck, Amy J Endourol Ureteroscopy and Percutaneous Procedures 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 cm(3) for the Trilogy and ShockPulse-SE groups, respectively. Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm(3)/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 Mary Ann Liebert, Inc., publishers 2021-09-01 2021-09-14 /pmc/articles/PMC8558064/ /pubmed/33843245 http://dx.doi.org/10.1089/end.2020.1097 Text en © Tim Large et al., 2021; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by/4.0/This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Ureteroscopy and Percutaneous Procedures
Large, Tim
Nottingham, Charles
Brinkman, Ethan
Agarwal, Deepak
Ferrero, Andrea
Sourial, Michael
Stern, Karen
Rivera, Marcelino
Knudsen, Bodo
Humphreys, Mitchel
Krambeck, Amy
Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
title Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
title_full Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
title_fullStr Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
title_full_unstemmed Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
title_short Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
title_sort multi-institutional prospective randomized control trial of novel intracorporeal lithotripters: shockpulse-se vs trilogy trial
topic Ureteroscopy and Percutaneous Procedures
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558064/
https://www.ncbi.nlm.nih.gov/pubmed/33843245
http://dx.doi.org/10.1089/end.2020.1097
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