Zeng Guohua, Jiang Kehua, Liu Shusheng, Wu Rongpei, Duan Xianzhong, Chai Chu Ann, Gökce Mehmet İlker, Gadzhiev Nariman, Kalathia Jaisukh, Wang Kefeng, Zhao Enyang, Song Rijin, Kei Yuen Steffi Kar, Gauhar Vineet, Teoh Jeremy Yuen Chun, Ma Jinxiang, Zhang Guangyuan, Zhu Xiaorui, Jiang Shuangjian, Wang Qing, Zhang Lin, Hua Yibo, Du Jingzeng, Bai Song, Li Xuedong, Li Zhenhua, Zhong Wen, Zhao Zhijian, Liu Yongda, Cao Jianwei, Zhu Wei
Department of Urology and Guangdong Key Laboratory of Urology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Urology, Guizhou Provincial People's Hospital. Guizhou, China.
Eur Urol. 2025 Jun 17. doi: 10.1016/j.eururo.2025.06.001.
The efficacy and safety of flexible ureteroscopy (f-URS) using a flexible and navigable suction ureteral access sheath (FANS) versus mini-percutaneous nephrolithotomy (mPCNL) for 2-3 cm renal stones remain controversial. Our aim was to conduct a study to address the evidence gap.
We conducted a multicenter, noninferiority, randomized controlled trial in which 720 patients were enrolled across 12 centers in China, Turkey, Russia, India, and Malaysia from August 2024 to February 2025. Patients with 2-3 cm stones were randomized 1:1 to FANS f-URS or mPCNL. The primary outcome was the immediate stone-free rate (SFR) (noninferiority margin -8%). Secondary outcomes included operative time, hospital stay, auxiliary procedures, 3-mo SFR, complications, and quality of life (QoL) improvement.
FANS f-URS was noninferior to mPCNL in terms of the immediate SFR (risk difference [RD] -1.4%, 95% confidence interval [CI] -6.7% to 3.9%; noninferiority 1-sided p = 0.007). FANS f-URS had a longer operative time (mean difference [MD] 29 min, 95% CI 24-33; p < 0.001), lower transfusion rate (RD -2.2%, 95% CI -3.9% to -0.5%; p = 0.021), shorter postoperative hospitalization (MD -2.5 d, 95% CI -2.8 to -2.2; p < 0.001), and a greater improvement in QoL score (MD 4.8, 95% CI 3.0-6.6; p < 0.001). We found no evidence of differences in auxiliary procedures, the 3-mo SFR, or infection-related complications.
FANS f-URS had a noninferior SFR in comparison to mPCNL for 2-3 cm renal stones, with lower risk of bleeding risk, shorter hospitalization, and superior QoL. These findings support FANS f-URS as a viable alternative to mPCNL for 2-3 cm stones.
对于2 - 3厘米的肾结石，使用可弯曲且可导航的输尿管吸引鞘（FANS）的软性输尿管镜检查（f - URS）与微通道经皮肾镜取石术（mPCNL）的疗效和安全性仍存在争议。我们的目的是开展一项研究以填补证据空白。
我们进行了一项多中心、非劣效性、随机对照试验，2024年8月至2025年2月期间在中国、土耳其、俄罗斯、印度和马来西亚的12个中心招募了720例患者。将患有2 - 3厘米结石的患者按1:1随机分为FANS f - URS组或mPCNL组。主要结局是即刻无石率（SFR）（非劣效界值为 - 8%）。次要结局包括手术时间、住院时间、辅助操作、3个月SFR水平、并发症以及生活质量（QoL）改善情况。
在即刻SFR方面，FANS f - URS不劣于mPCNL（风险差异[RD]为 - 1.4%，95%置信区间[CI]为 - 6.7%至3.9%；非劣效性单侧p = 0.007）。FANS f - URS的手术时间更长（平均差异[MD]为29分钟，95% CI为24 - 33；p < 0.001），输血率更低（RD为 - 2.2%，95% CI为 - 3.9%至 - 0.5%；p = 0.021），术后住院时间更短（MD为 - 2.5天，95% CI为 - 2.8至 - 2.2；p < 0.001），且QoL评分改善更大（MD为4.8，95% CI为3.0 - 6.6；p < 0.001）。我们未发现辅助操作、3个月SFR水平或感染相关并发症存在差异的证据。
对于2 - 3厘米的肾结石，FANS f - URS与mPCNL相比SFR不劣，且出血风险更低、住院时间更短、生活质量更优。这些发现支持FANS f - URS作为2 - 3厘米结石mPCNL的一种可行替代方案。
