■逆行肾内手术(RIRS)是上尿路结石的主要治疗方法。输尿管进入鞘(UAS)作为补充工具,促进RIRS期间直接进入肾脏。缺乏将尖端可弯曲吸引输尿管入路鞘(S-UAS)与RIRS中的传统UAS进行比较以治疗肾和输尿管结石的高质量证据。该研究的目的是比较S-UAS与传统UAS在RIRS中治疗≤30mm的肾脏或输尿管结石的疗效和安全性。
■国际,多中心,优势随机对照试验纳入了中国8个医疗中心的320名意向治疗患者,菲律宾,马来西亚和土耳其从2023年8月到2024年2月。纳入标准为≥18岁的肾结石或输尿管结石≤30mm的患者。使用S-UAS或传统UAS进行RIRS。主要结果是立即无石率(SFR)。次要结果包括术后3个月SFR,操作时间,住院,辅助程序,并发症(使用Clavien-Dindo分级系统),和生活质量(QoL)评分的改善。提供了比例[风险差异(RD)]/均值[平均差(MD)]和95%置信区间(CI)之间的差异。本研究在ClinicalTrials.gov:NCT05952635注册。
■与传统UAS组相比,S-UAS组表现出明显更高的立即SFR(81.3%对49.4%;RD31.9%;95%CI22.5%-41.7%;p=0.004),由单边优势测试确定。此外,S-UAS组在术后3个月表现出更高的SFR(87.5%对70.0%;RD17.5%;95%CI8.7%-26.3%;p<0.001),术后发热率降低(RD-11.9%;95%CI-18.7%至-4.9%;p<0.001),减少石篮的使用(RD-70.6%;95%CI-77.8%至-63.5%;p<0.001),和更好的QoL改善(MD7.25;95%CI2.21-12.29;p=0.005)。手术时间差异无统计学意义,住院,或需要第二阶段RIRS。
■在上尿路结石≤30mm的RIRS中,与传统UAS相比,S-UAS表现出卓越的性能,显示更高的SFR,术后发热率降低,并改善QoL结果。S-UAS成为RIRS传统UAS的审慎和有利的替代方案。
■国家自然科学基金和广东省,和浙江省医药卫生计划。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: National Natural Science Foundation of China and Guangdong Province, and Zhejiang Medicine and Health Program.