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

Authors

Donglai Shen, Shoupeng Li, Zhi Li, Haomin Liang, Wei Zhu, Hairui Chen, Jisong Tian, Wei Wang, Xu Zhang, Bingding Huang, Haixing Mai

Published in

European urology focus. Oct 01, 2026. Epub Oct 01, 2026.

Abstract

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.
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.
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.
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.

PMID:
42823258
Bibliographic data and abstract were imported from PubMed on 02 Oct 2026.

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