To compare the clinical outcomes of lithotripsy using the 100W Ho:YAG laser and the Trilogy™ lithotripter in Mini-PCNL, and to determine the most effective method for stone clearance through a miniaturized percutaneous tract.
This double-blind, randomized, single-center controlled trial (ClinicalTrials.gov ID: NCT04559321) enrolled patients with GUY's grade 1-2 kidney stones. Participants were randomly assigned to undergo Mini-PCNL using either the 100W Ho:YAG laser (Lumenis Pulsed® 100 H) or the 1.5 mm Trilogy™ lithotripter (EMS-Nyon). Primary endpoints were stone lithotripsy time (SLT), lithotripsy rate (SLR), and stone-free rate (SFR). SLT was defined as the time from first activation of the lithotripter/laser until no further activations were needed. The study was terminated early in August 2023 following DSMB recommendations due to evidence of efficacy in one arm.
Eighty-three patients were analyzed (laser, n=40; Trilogy™, n=43), with comparable demographic and stone characteristics. Mean SLT was 8.02 min (laser) vs. 5.7 min (Trilogy™, p = 0.199). SLR was 179 vs. 212 mm³/min (p = 0.218), and operative time was 75.1 ± 26.6 vs. 85.9 ± 28.1 min (p = 0.077). Trilogy™ achieved a significantly higher SFR (88.4% vs. 70%, p = 0.038). Complication rates were low (2.3% Trilogy™ vs. 10% laser, p = 0.142). Residual stone volume did not differ significantly between groups.
Trilogy™ lithotripsy resulted in higher SFR without increasing operative time or complications, supporting its use as an effective alternative to high-power laser lithotripsy in Mini-PCNL, especially where active suction is unavailable.
Urology. 2025 Apr 08 [Epub ahead of print]
Manzo Braulio O, Lozada Hernández Edgard Efrén, Casale Allan R, Jimenez J Christopher J, Gomez Yonathan R, Galvan Juan P, Alarcon Pompeyo, Flores Edson, Méndez Daniela M, Sanchez Hector M
Bajio´s High Specialty Hospital IMSS Bienestar, Endourology Department. Electronic address: ., Bajio´s High Specialty Hospital IMSS Bienestar, Investigation Department., Bajio´s High Specialty Hospital IMSS Bienestar, Endourology Department.