Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial.
Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial.
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新型腔内碎石机的多机构前瞻性随机对照试验：ShockPulse-SE与Trilogy试验。
DOI：
10.1089/end.2020.1097
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发表时间：
2021-09
影响因子：
2.7
通讯作者：
Krambeck A
中科院分区：
文献类型：
--
作者：
Large T;Nottingham C;Brinkman E;Agarwal D;Ferrero A;Sourial M;Stern K;Rivera M;Knudsen B;Humphreys M;Krambeck A
引言：目前，有多种腔内碎石机可用于经皮肾镜取石术（PCNL）。本研究旨在评价两种新型碎石机：Trilogy和ShockPulse-SE的有效性。材料与方法：这是一项前瞻性多机构随机试验，比较了2019年2月至2020年6月期间使用两种新型碎石机进行PCNL的结局。该研究评估了结石清除时间、结石清除率、器械故障、结石清除率和并发症的客观指标。由主治外科医生通过术后即刻调查提供器械评估。结果：使用Trilogy或ShockPulse-SE碎石机完成了100例标准PCNL。使用定量结石分析软件估计结石体积，Trilogy和ShockPulse-SE组的平均结石体积分别为4.18 ± 4.79和3.86 ± 3.43 cm 3。Trilogy与ShockPulse-SE的结石清除率分别为1.22 ± 1.67和0.77 ± 0.68 cm 3/min（p = 0.0542）。在多变量分析中比较Trilogy与ShockPulse-SE时，（104.4 ± 48.2分钟vs 121.1 ± 59.2分钟，p = 0.126），二次手术率（17.65% vs 40.81%，p = 0.005）和器械故障（1.96% vs 34.69%，p < 0.001）分别较少。两种器械的最终结石清除率无差异。结论：Trilogy和ShockPulse-SE碎石机均能高效清除较大肾结石。在本研究中，我们注意到两种器械之间的差异，包括使用Trilogy器械时器械故障较少。临床试验ID编号：NCT 03959683
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
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