Research output: Contribution to journal › Article › peer-review
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. / Zhu, Wei; Ann Chai, Chu; Ma, Jinxiang; İlker Gökce, Mehmet; Gadzhiev, Nariman; Kalathia, Jaisukh; Jiang, Kehua; Duan, Xianzhong; Cao, Jianwei; Wu, Rongpei; Song, Rijin; Bai, Song; Li, Xuedong; Liu, Shusheng; Zeng, Guohua.
In: European Urology Open Science, Vol. 70, 12.2024, p. 167-173.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3-cm Renal Stones
T2 - Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial
AU - Zhu, Wei
AU - Ann Chai, Chu
AU - Ma, Jinxiang
AU - İlker Gökce, Mehmet
AU - Gadzhiev, Nariman
AU - Kalathia, Jaisukh
AU - Jiang, Kehua
AU - Duan, Xianzhong
AU - Cao, Jianwei
AU - Wu, Rongpei
AU - Song, Rijin
AU - Bai, Song
AU - Li, Xuedong
AU - Liu, Shusheng
AU - Zeng, Guohua
N1 - © 2024 The Author(s).
PY - 2024/12
Y1 - 2024/12
N2 - 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.
AB - 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.
U2 - 10.1016/j.euros.2024.10.014
DO - 10.1016/j.euros.2024.10.014
M3 - Article
C2 - 39559532
VL - 70
SP - 167
EP - 173
JO - European Urology Open Science
JF - European Urology Open Science
SN - 2666-1691
ER -
ID: 135968945