Tasian Gregory E, Chu David I, Nelson Caleb P, DeFoor W Robert, Ziemba Justin B, Huang Jing, Luan Xianqun, Kurtz Michael, Ching Christina B, Dangle Pankaj, Schaeffer Anthony J, Sturm Renea, Wu Wayland, Bayne Christopher, Fernandez Nicolas, Chua Michael E, DeMarco Romano, Ellsworth Pamela, Augelli Brian, Bi-Karchin Jing, McCune Rebecca D, Vatsky Seth, Back Susan, Wang Zi, Beck Hunter, Kurth Anna, Kurth Laura, Pleskoff Annabelle, Forrest Christopher B, Ellison Jonathan S, Rove Kyle, Sparks Scott, Nelson Eric, Schlomer Bruce, Krill Aaron, Tong Ching Man Carmen, Taylor Abby, Ramachandra Puneeta, Stec Andrew, Casale Pasquale, Coplen Douglas, Janzen Nicolette, Bagley Krystal, Denburg Michelle R, Dickinson Kimberley, Laberee Rosemary, Lorenzo Matt, Selman-Fermin Antoine, Dos Santos Joana, Grant Campbell, Kraft Kate, Meenakshi-Sundaram Bhalaajee
Division of Urology, Department of Surgery, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.
JAMA Netw Open. 2025 Aug 1;8(8):e2525789. doi: 10.1001/jamanetworkopen.2025.25789.
Most children and adolescents with kidney and ureteral stones are treated with ureteroscopy, despite the uncertainty and equal weight of guideline recommendations for ureteroscopy or shockwave lithotripsy.
To compare stone clearance and patient-reported outcomes among children and adolescents after ureteroscopy or shockwave lithotripsy.
DESIGN, SETTING, AND PARTICIPANTS: This nonrandomized clinical trial enrolled patients between March 16, 2020, and July 31, 2023, at 31 medical centers in the US and Canada. Patients aged 8 to 21 years with kidney stones, ureteral stones, or both were included. Follow-up was completed on October 15, 2023.
Ureteroscopy or shockwave lithotripsy.
The primary outcome was stone clearance assessed by standardized ultrasonography 6 (±2) weeks after surgery. Using inverse probability weighting and random intercepts for site, stone clearance was evaluated per kidney or ureter using logistic regression and estimated stone clearance rates were generated for each procedure.
This study included 1142 patients (690 females [60.4%]), with a median age of 15.6 years (IQR, 12.6-17.3 years). In terms of race and ethnicity, 41 patients (3.6%) were Black, 130 (11.4%) were Hispanic, and 884 (77.4%) were White. A total of 124 urologists treated 1069 and 197 kidneys or ureters with ureteroscopy and shockwave lithotripsy (n = 953 and n = 189 patients), respectively, with a median stone size of 6.0 mm (IQR, 4.0-9.0 mm). Ureteral stents were placed at time of index surgery for 841 procedures for 767 patients (80.4%) receiving ureteroscopy and for 6 procedures for 5 patients (2.6%) receiving shockwave lithotripsy. Stone clearance occurred in 474 patients who underwent ureteroscopy (71.2% [95% CI, 63.8%-78.5%]) and in 105 patients who underwent shockwave lithotripsy (67.5% [95% CI, 61.0%-74.1%]), a difference that was not statistically significant (risk difference, 3.6% [95% CI, -6.2% to 13.5%]). Compared with shockwave lithotripsy, ureteroscopy resulted in greater pain interference (T-score difference, 5.0 [95% CI, 2.3-7.8]) and urinary symptoms (symptom score difference, 3.9 [95% CI, 1.2-6.7]) 1 week after surgery. Patients who had ureteroscopy missed more school (risk difference, 21.3% [95% CI, 9.7%-32.8%]) and caregivers missed more work (risk difference, 23.0% [95% CI, 11.0%-35.0%]) in the week after surgery.
In this study of 1142 children and adolescents with kidney and ureteral stones, there was no clinically meaningful difference in stone clearance with ureteroscopy vs shockwave lithotripsy. Shockwave lithotripsy was associated with better patient-reported outcomes. These findings raise questions about the preference for ureteroscopy in practice.
ClinicalTrials.gov Identifier: NCT04285658.
尽管关于输尿管镜检查或冲击波碎石术的指南建议存在不确定性且权重相同，但大多数患有肾结石和输尿管结石的儿童及青少年仍接受输尿管镜检查治疗。
比较输尿管镜检查或冲击波碎石术后儿童及青少年的结石清除率和患者报告的结局。
设计、地点和参与者：这项非随机临床试验于2020年3月16日至2023年7月31日在美国和加拿大的31个医疗中心招募患者。纳入年龄在8至21岁、患有肾结石、输尿管结石或两者皆有的患者。随访于2023年10月15日完成。
输尿管镜检查或冲击波碎石术。
主要结局是术后6（±2）周通过标准化超声评估的结石清除情况。使用逆概率加权法和各地点的随机截距，通过逻辑回归对每个肾脏或输尿管的结石清除情况进行评估，并为每种手术生成估计的结石清除率。
本研究纳入了1142例患者（690例女性[60.4%]），中位年龄为15.6岁（四分位间距，12.6 - 17.3岁）。在种族和族裔方面，41例患者（3.6%）为黑人，130例（11.4%）为西班牙裔，884例（77.4%）为白人。共有124名泌尿科医生分别对1069个和197个肾脏或输尿管进行了输尿管镜检查和冲击波碎石术（n = 953例和n = 189例患者），结石中位大小为6.0 mm（四分位间距，4.0 - 9.0 mm）。在接受输尿管镜检查的767例患者（80.4%）的初次手术时放置了输尿管支架841例，在接受冲击波碎石术的5例患者（2.6%）的初次手术时放置了输尿管支架6例。接受输尿管镜检查的474例患者（71.2% [95%置信区间，63.8% - 78.5%]）和接受冲击波碎石术的105例患者（67.5% [95%置信区间，61.0% - 74.1%]）实现了结石清除，差异无统计学意义（风险差异，3.6% [95%置信区间，-6.2%至13.5%]）。与冲击波碎石术相比，输尿管镜检查在术后1周导致更大的疼痛干扰（T评分差异，5.0 [95%置信区间，2.3 - 7.8]）和泌尿系统症状（症状评分差异，3.9 [95%置信区间，1.2 - 6.7]）。接受输尿管镜检查的患者在术后一周缺课更多（风险差异，21.3% [95%置信区间，9.7% - 32.8%]），护理人员误工更多（风险差异，23.0% [95%置信区间，11.0% - 35.0%]）。
在这项对1142例患有肾结石和输尿管结石的儿童及青少年的研究中，输尿管镜检查与冲击波碎石术在结石清除方面没有临床意义上的差异。冲击波碎石术与更好的患者报告结局相关。这些发现引发了关于实践中对输尿管镜检查偏好的疑问。
ClinicalTrials.gov标识符：NCT04285658
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