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

Abstract

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 < 0.001) and tract establishment time (236 vs 480 s; p < 0.001) were shorter with D-CEUS. Median hospital stay was shorter (2 vs 5 d; p < 0.001), with lower hemoglobin loss (median 7.0 vs 11.5 g/l; p = 0.023). There was no significant difference in the complication rate (8.2% vs 15%; p = 0.19). A limitation is that the open-label design may compromise the robustness of the findings.

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.