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Comparative Effectiveness Of Percutaneous Nephrolithotomy Compared To Ureteroscopy Or Shockwave Lithotripsy: Results Of A Multicenter Prospective Clinical Trial
Jonathan S. Ellison, MD1, David Chu, MD, MSCE2, Caleb Nelson, MD, MPH3, Justin Ziemba, MD, MSEd4, W. Robert DeFoor, MD, MPH5, Xianqun Luan, MS6, Jing Huang, PhD4, Romano DeMarco, MD7, Christopher Bayne, MD7, Christina Ching, MD8, Michael Chua, MD, MASc (GH), DPBU, FPUA, FPSPU, FPhilGURS9, Pankaj Dangle, MD, MCh, FAAP10, Nicolas Fernandez, MD, PhD11, Eric Nelson, MD12, Joana Dos Santos, MD, MHSc, FRCPC9, Anthony Schaeffer, MD, MPH13, Renea Sturm, MD14, Wayland WU, MD15, Susan Back, MD6, Brian Augelli, BS6, Jing Karchin, PhD6, Rebecca D. McCune, MS6, Badar Omar, BS3, Annabelle Pleskoff, MS.Ed16, Gregory E. Tasian, MD, MSc, MSCE6.
1Medical College of Wisconsin, Milwaukee, WI, USA, 2Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA, 3Boston Children's Hospital, Boston, MA, USA, 4University of Pennsylvania, Philadelphia, PA, USA, 5Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA, 6Children's Hospital of Philadelphia, Philadelphia, PA, USA, 7University of Florida Health Shands Children's Hospital, Gainesville, FL, USA, 8Nationwide Children's Hospital, Columbus, OH, USA, 9Toronto SickKids, Toronto, ON, Canada, 10 Riley Hospital for Children, Indianapolis, IN, USA, 11Seattle Children's Hospital, Seattle, WA, USA, 12Children's Hospital of Richmond at VCU, Richmond, VA, USA, 13University of Utah, Salt Lake City, UT, USA, 14Mattel Children's Hospital at UCLA, Los Angeles, CA, USA, 15Cohen Children's Medical Center, New Hyde Park, NY, USA, 16Children’s Hospital of Philadelphia (Patient & Family Research Partners), Philadelphia, PA, USA.


Background: Clinical guidelines for the surgical management of pediatric patients recommend either percutaneous nephrolithotomy (PCNL) or shockwave lithotripsy (SWL) based only on expert opinion. Our objective was to compare outcomes of PCNL to ureteroscopy (URS) and SWL in pediatric patients, with an emphasis on heterogeneity of treatment effect for stone size and location.
Methods: We performed a prospective observational clinical trial of patients 8-21 years of age having PCNL, URS, or SWL for kidney and/or ureteral stones between 2020-2023. The trial was embedded within clinical care in the 30 North American hospitals that comprise the Pediatric KIDney Stone (PKIDS) Care Improvement Network. The primary outcome of stone clearance was assessed by ultrasound 6 (±2) weeks after surgery, considering heterogeneity of treatment effect by stone size (<7mm, 7-10mm, 11-15mm, and >15mm) and location (lower pole kidney, non-lower pole kidney, and ureter). Patient-reported outcomes (PROs) were measured by pediatric PROMIS instruments and urinary symptom scores after surgery, assessing heterogeneity of treatment effect by age and sex. Other secondary outcomes were unanticipated health care visits and surgical complications. In an intent-to-treat analysis, stone clearance and PROs were compared using generalized linear models and ANCOVA, respectively, weighted with inverse propensity scores to balance patient, surgeon, and institutional characteristics across groups. The ANCOVA analysis of PROs accounted for differences between groups at baseline.
Results: Among 1290 patients with a median age of 15 years (IQR 12, 17), 98, 1070, 197 kidneys were treated with PCNL, URS and SWL, respectively, by 125 urologists. Thirty-six, 3, and 28 patients had URS, SWL, and PCNL for stones >15mm, respectively. For the entire cohort, there were no differences in stone clearance between PCNL and either URS or SWL. However, stone clearance was higher PCNL compared to ureteroscopy (risk difference 35.1%; 95% confidence interval, 16.3 to 53.8) for patients with stones >15mm. Due to the small sample size of patients undergoing SWL for stones > 15 mm, no meaningful comparisons between SWL and PCNL could be made for larger stones. No differences were detected between treatments based upon stone location within the ureter, lower pole, or non-lower pole. Compared to URS, PCNL was associated with better urinary symptoms, pain, stress, anxiety, and sleep disturbances one week after surgery (see Table). No differences in unplanned hospital visits or surgical complications were noted between groups.
Conclusions: Compared to URS, PCNL was found to have greater stone clearance for stones >15 mm and better patient-reported outcomes in the first week after surgery compared to ureteroscopy. The PKIDS trial provides level 2 evidence supporting PCNL as the first-line surgical management in children with kidney stones >15 mm. Use of SWL for kidney stones >15mm was exceedingly rare in this trial reflecting real world care, demonstrating its lack of clinical relevance for large kidney stones. These results support revision of guidelines to reflect these findings.

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