First-in-clinical Evaluation of Dual Contrast-enhanced Ultrasound-guided PCNL: A Multicenter Randomized Trial Versus Fluoroscopy

Background and objective Puncture is critical in percutaneous nephrolithotomy (PCNL), influencing access failure and vascular or adjacent organ injury. This study aimed to compare the clinical efficacy and safety of dual contrast-enhanced ultrasound (D-CEUS) with fluoroscopic guidance for renal access during PCNL.Methods This two-center prospective trial was conducted between January 2024 and November 2024. A total of 150 patients were randomized to the D-CEUS group (n = 75) or the fluoroscopy group (n = 75). Outcomes included first-attempt puncture success rate, puncture and tract establishment time, stone-free rate, hospital stay, hemoglobin changes, and complications.Key findings and limitations In the intention-to-treat analysis, the first-attempt puncture success rate was higher with D-CEUS than with fluoroscopy (92% vs 80%; difference 12%, 95% confidence interval [CI] = 0.77-23%; Mantel-Haenszel odds ratio [OR] 2.87, 95% CI = 1.04-7.87; p = 0.040). The per-protocol analysis showed consistent results (95% vs 83%; difference 11%, 95% CI = 0.81-22%; Mantel-Haenszel OR 3.45, 95% CI = 1.06-11.24; p = 0.040). Median puncture time (56 vs 120 s; p Conclusions and clinical implications D-CEUS facilitates accurate and safe puncture, efficient tract establishment, and real-time confirmation of calyceal access while avoiding radiation exposure. These findings support further evaluation of D-CEUS as a radiation-free alternative to fluoroscopy for renal access during PCNL.