Randomized Controlled Trial Comparing Three Different Modalities of Lithotrites for Intracorporeal Lithotripsy in Percutaneous Nephrolithotomy
Randomized Controlled Trial Comparing Three Different Modalities of Lithotrites for Intracorporeal Lithotripsy in Percutaneous Nephrolithotomy
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DOI：
10.1089/end.2017.0436
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发表时间：
2017-11-03
影响因子：
2.7
通讯作者：
Lingeman, James E.
中科院分区：
文献类型：
--
作者：
York, Nadya E.;Borofsky, Michael S.;Lingeman, James E.
目的：比较三种型号的体内碎石机在经皮肾镜取石术（PCNL）中的效率（结石碎裂和取出时间）及并发症。材料与方法：2009 - 2016年在北美9个中心进行前瞻性、随机对照试验。患者被随机分配到三种碎石装置中的一种：Cyberwand，一种双探头超声装置；瑞士Lithoclast Select，一种气动和超声波组合装置；以及StoneBreaker，这是一种由二氧化碳粉盒驱动的便携式气动装置。由于破碎机缺乏超声波组件，因此它与us - ii超声波碎石机一起使用，以便与组合设备进行公平比较。结果：纳入270例患者，随机分组后排除69例。221名患者完成了这项研究：Cyberwand组71名，Lithoclast Select组66名，StoneBreaker组64名。三组患者的基线特征相似。StoneBreaker组的平均石头表面积较小，为407.8mm(2)，而Lithoclast Select组为577.5mm(2)， Cyberwand组为627.9mm(2)。StoneBreaker组的石头清除速度最慢，为24.0mm(2)/min，而Lithoclast Select组和Cyberwand组分别为28.9mm(2)/min和32.3mm(2)/min。经统计调整StoneBreaker组平均结石较小，三组间结石清除率无差异（p = 0.249）。包括并发症和无结石率在内的次要结果在两组之间相似。结论：Cyberwand， Lithoclast Select和StoneBreaker碎石机在PCNL中对直径为20 - 2cm的石块有相似的调整后的石头清除率。这些装置的安全性和有效性是相当的。
Purpose: To compare the efficiency (stone fragmentation and removal time) and complications of three models of intracorporeal lithotripters in percutaneous nephrolithotomy (PCNL).Materials and Methods: Prospective, randomized controlled trial at nine centers in North America from 2009 to 2016. Patients were randomized to one of three lithotripter devices: the Cyberwand, a dual-probe ultrasonic device; the Swiss Lithoclast Select, a combination pneumatic and ultrasonic device; and the StoneBreaker, a portable pneumatic device powered by CO2 cartridges. Since the StoneBreaker lacks an ultrasonic component, it was used with the LUS-II ultrasonic lithotripter to allow fair comparison with combination devices.Results: Two hundred seventy patients were enrolled, 69 were excluded after randomization. Two hundred one patients completed the study: 71 in the Cyberwand group, 66 in the Lithoclast Select group, and 64 in the StoneBreaker group. The baseline patient characteristics of the three groups were similar. Mean stone surface area was smaller in the StoneBreaker group at 407.8mm(2)vs 577.5mm(2) (Lithoclast Select) and 627.9mm(2) (Cyberwand). The stone clearance rate was slowest in the StoneBreaker group at 24.0mm(2)/min vs 28.9mm(2)/min and 32.3mm(2)/min in the Lithoclast Select and Cyberwand groups, respectively. After statistically adjusting for the smaller mean stone in the StoneBreaker group, there was no difference in the stone clearance rate among the three groups (p = 0.249). Secondary outcomes, including complications and stone-free rates, were similar between the groups.Conclusions: The Cyberwand, Lithoclast Select, and the StoneBreaker lithotripters have similar adjusted stone clearance rates in PCNL for stones > 2cm. The safety and efficacy of these devices are comparable.