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 < 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.