Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study

作者：Wei Zhu, Shusheng Liu, Jianwei Cao, Hao Wang, Hui Liang, Kehua Jiang, Yu Cui, Chu Ann Chai, Emre Burak Şahinler, Albert Aquino, Giorgio Mazzon, Wen Zhong, Zhijian Zhao, Lin Zhang, Jie Ding, Qing Wang, Yizhou Wang, Kelven Weijing Chen, Yongda Liu, Simon Choong, Kemal Sarıca, Guohua Zeng · 发表于：EClinicalMedicine · 年份：2024 · DOI：10.1016/j.eclinm.2024.102724 · 被引用次数：124 · 研究领域：Kidney Stones and Urolithiasis Treatments、Ureteral procedures and complications、Urinary Tract Infections Management

Background: 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. Methods: 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. Findings: The S-UAS group demonstrated a significantly higher immediately SFR (81.3% versus 49.4%;...