Ultrasonography and fluoroscopy-guided PCNL vs pure ultrasonography-guided endoscopic combined intrarenal surgery for 4-6-cm kidney stones.

Abstract

To assess the safety and efficacy of combined ultrasonography (US) and fluoroscopy-guided percutaneous nephrolithotomy (CG-PCNL) vs pure US-guided endoscopic combined intrarenal surgery (USG-ECIRS) for treating 4-6-cm renal calculi. This prospective randomised trial was conducted in the period May 2022 to April 2025 at the Second Affiliated Hospital of Anhui Medical University and Zhongda Hospital of Southeast University. A total of 114 consecutive patients with 4-6-cm renal calculi were randomly assigned to undergo CG-PCNL or USG-ECIRS, with 57 patients per group. The primary outcomes of the study were the first stone-free rate (SFR) and tract establishment success rate, with secondary outcomes including operating time, haemoglobin drop and complication rate. The study was registered at http://www.chictr.org.cn (ChiCTR2200057865). A total of 106 patients were included in the analysis, with 53 in each group. The two groups had similar baseline characteristics. There was no significant difference in first SFR between the groups (81.1% vs 79.2%; P = 0.872). In patients with S.T.O.N.E. scores >10 or stones involving more than five calyces, SFR was markedly lower in both groups. No intergroup differences were detected in either tract establishment time or initial success rate. The operating time in the CG-PCNL group was significantly longer than that in the USG-ECIRS group (143.2 vs 93.6 min; P < 0.001). Haemoglobin drop was significantly more pronounced in the CG-PCNL group compared to the USG-ECIRS group (14.9 vs 10.3 g/L; P = 0.043). The overall incidence of complications in the CG-PCNL group was significantly higher than that in the USG-ECIRS group (18.9% vs 5.7%; P = 0.038). Use of USG-ECIRS showed comparable efficacy to use of CG-PCNL in the management of 4-6-cm renal calculi, while demonstrating superior safety with fewer complications and less blood loss. However, the SFR declined for both approaches when the S.T.O.N.E. score exceeded 10 or when stones involved more than five calyces.