Zhu Wei, Liu Shusheng, Cao Jianwei, Wang Hao, Liang Hui, Jiang Kehua, Cui Yu, Chai Chu Ann, Sahinler Emre Burak, Aquino Albert, Mazzon Giorgio, Zhong Wen, Zhao Zhijian, Zhang Lin, Ding Jie, Wang Qing, Wang Yizhou, Chen Kelven Weijing, Liu Yongda, Choong Simon, Sarica Kemal, Zeng Guohua
Department of Urology and Guangdong Key Laboratory of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Department of Urology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University, School of Medicine, Shanghai, China.
EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.
Retrograde intrarenal surgery (RIRS) is the main treatments for upper urinary tract stones. The Ureteral Access Sheath (UAS) serves as a supplementary tool, facilitating direct kidney access during RIRS. High quality of evidence comparing tip bendable suction ureteral access sheath (S-UAS) with traditional UAS in RIRS for the treatment of renal and ureteral stones is lacking. The purpose of the study is to compare the efficacy and safety of S-UAS with traditional UAS in RIRS for the treatment of renal or ureteral stones ≤30 mm.
An international, multicenter, and superiority randomized controlled trial included 320 intention-to-treat patients across 8 medical centers in China, the Philippines, Malaysia and Turkey from August 2023 to February 2024. The inclusion criteria were patients ≥18 years old with renal or ureteral stones ≤30 mm. RIRS was performed using either S-UAS or traditional UAS. The primary outcome was the immediately stone-free rate (SFR). Secondary outcomes included SFR 3 months after operation, operating time, hospital stay, auxiliary procedures, complications (using the Clavien-Dindo grading system), and improvement in the Quality of Life (QoL) score. Differences between proportions [risk difference (RD)]/means [mean difference (MD)] and 95% confidence intervals (CI) were presented. This study is registered at ClinicalTrials.gov: NCT05952635.
The S-UAS group demonstrated a significantly higher immediately SFR (81.3% versus 49.4%; RD 31.9%; 95% CI 22.5%-41.7%; p = 0.004) compared to the traditional UAS group, as determined by the one-side superiority test. Additionally, the S-UAS group exhibited a higher SFR at 3 months post-operation (87.5% versus 70.0%; RD 17.5%; 95% CI 8.7%-26.3%; p < 0.001), lower postoperative fever rate (RD -11.9%; 95% CI -18.7% to -4.9%; p < 0.001), reduced use of stone baskets (RD -70.6%; 95% CI -77.8% to -63.5%; p < 0.001), and better QoL improvement (MD 7.25; 95% CI 2.21-12.29; p = 0.005). No statistically significant differences were observed in operation time, hospital stay, or the need for second-stage RIRS.
In RIRS for upper urinary tract stones ≤30 mm, S-UAS exhibited superior performance compared to traditional UAS, demonstrating higher SFR, reduced postoperative fever rate, and improved QoL outcomes. S-UAS emerges as a prudent and advantageous alternative to traditional UAS for RIRS.
National Natural Science Foundation of China and Guangdong Province, and Zhejiang Medicine and Health Program.
逆行性肾内手术（RIRS）是上尿路结石的主要治疗方法。输尿管通路鞘（UAS）作为一种辅助工具，在RIRS期间有助于直接进入肾脏。缺乏高质量证据比较尖端可弯曲吸引输尿管通路鞘（S-UAS）与传统UAS在RIRS治疗肾和输尿管结石中的效果。本研究的目的是比较S-UAS与传统UAS在RIRS治疗直径≤30mm的肾或输尿管结石中的疗效和安全性。
一项国际、多中心、优效性随机对照试验，纳入了2023年8月至2024年2月在中国、菲律宾、马来西亚和土耳其的8个医疗中心的320例意向性治疗患者。纳入标准为年龄≥18岁、患有直径≤30mm的肾或输尿管结石的患者。使用S-UAS或传统UAS进行RIRS。主要结局是即刻无石率（SFR）。次要结局包括术后3个月的SFR、手术时间、住院时间、辅助操作、并发症（使用Clavien-Dindo分级系统）以及生活质量（QoL）评分的改善情况。呈现比例差异[风险差异（RD）]/均值差异[均值差异（MD）]及95%置信区间（CI）。本研究已在ClinicalTrials.gov注册：NCT05952635。
通过单侧优效性检验确定，与传统UAS组相比，S-UAS组的即刻SFR显著更高（81.3%对49.4%；RD 31.9%；95%CI 22.5%-41.7%；p = 0.004）。此外，S-UAS组术后3个月的SFR更高（87.5%对70.0%；RD 17.5%；95%CI 8.7%-26.3%；p < 0.001），术后发热率更低（RD -11.9%；95%CI -18.7%至-4.9%；p < 0.001），结石篮使用减少（RD -70.6%；95%CI -77.8%至-63.5%；p < 0.001），且QoL改善更好（MD 7.25；95%CI 2.21 - 12.29；p = 0.005）。在手术时间、住院时间或二期RIRS需求方面未观察到统计学显著差异。
在RIRS治疗直径≤30mm的上尿路结石中，S-UAS与传统UAS相比表现更优，显示出更高的SFR、更低的术后发热率以及更好的QoL结局。S-UAS成为RIRS中传统UAS的一种谨慎且有利的替代方案。
中国国家自然科学基金、广东省基金以及浙江省医药卫生项目。
