Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2–3-cm Renal Stones: Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial

IF 3.2 3区医学 Q1 UROLOGY & NEPHROLOGY

European Urology Open Science Pub Date : 2024-11-04 DOI:10.1016/j.euros.2024.10.014

Wei Zhu , Chu Ann Chai , Jinxiang Ma , Mehmet İlker Gökce , Nariman Gadzhiev , Jaisukh Kalathia , Kehua Jiang , Xianzhong Duan , Jianwei Cao , Rongpei Wu , Rijin Song , Song Bai , Xuedong Li , Shusheng Liu , Guohua Zeng

{"title":"Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2–3-cm Renal Stones: Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial","authors":"Wei Zhu , Chu Ann Chai , Jinxiang Ma , Mehmet İlker Gökce , Nariman Gadzhiev , Jaisukh Kalathia , Kehua Jiang , Xianzhong Duan , Jianwei Cao , Rongpei Wu , Rijin Song , Song Bai , Xuedong Li , Shusheng Liu , Guohua Zeng","doi":"10.1016/j.euros.2024.10.014","DOIUrl":null,"url":null,"abstract":"<div><div>Guidelines recommend percutaneous nephrolithotomy (PCNL) for larger renal stones, but advances in flexible ureteroscopy (f-URS) with a tip-bendable suction ureteral access sheath (S-UAS) have prompted further investigation. Our multicenter, international, randomized controlled trial is investigating whether f-URS with S-UAS is noninferior to mini-PCNL (mPCNL) for renal stones of 2–3 cm. The primary objective is the immediate stone-free rate (SFR). Secondary outcomes include the 3-mo SFR, complication rates, surgical time, hospital stay, auxiliary procedures, and improvements in quality of life. A total of 720 patients from 12 urological centers will be randomized to either f-URS with S-UAS or PCNL. Statistical analyses will include intention-to-treat and per-protocol approaches, with specific methods for normally and non-normally distributed data. Subgroup analyses will focus on stone location and lithotripter types. The significance threshold will be set at <em>p</em> < 0.05. The aim of this trial is to generate high-level evidence regarding the noninferiority of f-URS with S-UAS compared to mPCNL for medium-sized renal stones.</div><div>The trial is registered on ClinicalTrials.gov as NCT06526390.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"70 ","pages":"Pages 167-173"},"PeriodicalIF":3.2000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Urology Open Science","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666168324011005","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Guidelines recommend percutaneous nephrolithotomy (PCNL) for larger renal stones, but advances in flexible ureteroscopy (f-URS) with a tip-bendable suction ureteral access sheath (S-UAS) have prompted further investigation. Our multicenter, international, randomized controlled trial is investigating whether f-URS with S-UAS is noninferior to mini-PCNL (mPCNL) for renal stones of 2–3 cm. The primary objective is the immediate stone-free rate (SFR). Secondary outcomes include the 3-mo SFR, complication rates, surgical time, hospital stay, auxiliary procedures, and improvements in quality of life. A total of 720 patients from 12 urological centers will be randomized to either f-URS with S-UAS or PCNL. Statistical analyses will include intention-to-treat and per-protocol approaches, with specific methods for normally and non-normally distributed data. Subgroup analyses will focus on stone location and lithotripter types. The significance threshold will be set at p < 0.05. The aim of this trial is to generate high-level evidence regarding the noninferiority of f-URS with S-UAS compared to mPCNL for medium-sized renal stones.

The trial is registered on ClinicalTrials.gov as NCT06526390.

查看原文本刊更多论文

在治疗 2-3 厘米肾结石时，使用带尖端可弯曲抽吸输尿管接入鞘的输尿管软镜与迷你经皮肾镜取石术的对比：国际、多中心、随机、平行组、非劣效性试验的研究方案

指南建议对较大的肾结石进行经皮肾镜取石术（PCNL），但带有尖端可弯曲的抽吸输尿管通路鞘（S-UAS）的柔性输尿管镜（f-URS）的进步促使人们进行进一步的研究。我们的多中心国际随机对照试验正在研究，对于 2-3 厘米的肾结石，使用 S-UAS 的 f-URS 是否不逊于微型 PCNL（mPCNL）。主要目标是即时无石率（SFR）。次要结果包括 3 个月无结石率、并发症发生率、手术时间、住院时间、辅助手术以及生活质量的改善。共有来自 12 个泌尿外科中心的 720 名患者将被随机分配到带有 S-UAS 的 f-URS 或 PCNL。统计分析将包括意向治疗法和按协议治疗法，并针对正态分布和非正态分布数据采用特定方法。亚组分析将侧重于结石位置和碎石机类型。显著性阈值将设定为 p < 0.05。该试验的目的是为f-URS联合S-UAS治疗中型肾结石与mPCNL相比的非劣效性提供高水平证据。该试验在ClinicalTrials.gov上注册为NCT06526390。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊