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
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 <i>p</i> < 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.
Authors
- Guohua Zeng (ORCID: https://orcid.org/0000-0002-3110-8933)
- Kehua Jiang (ORCID: https://orcid.org/0000-0002-9446-3158)
- Xianzhong Duan (ORCID: https://orcid.org/0000-0002-9492-1243)
- Chu Ann Chai (ORCID: https://orcid.org/0000-0001-8915-3617)
- Wei Ming Zhu (ORCID: https://orcid.org/0000-0003-0673-3048)
- Rijin Song
- Rongpei Wu
- Mehmet İlker Gökçe (ORCID: https://orcid.org/0000-0002-2370-548X)
- Jaisukh Kalathia
- Song Bai (ORCID: https://orcid.org/0000-0002-3802-621X)
- Nariman K. Gadzhiev (ORCID: https://orcid.org/0000-0002-6255-0193)
- Xuedong Li (ORCID: https://orcid.org/0000-0002-1872-4213)
- Shusheng Liu (ORCID: https://orcid.org/0000-0002-8760-5090)
- Jinxiang Ma
- Jianwei Cao (ORCID: https://orcid.org/0000-0002-6664-7080)
Institutions
- University Malaya Medical Centre (MY)
- Ankara University (TR)
- Harbin Medical University (CN)
- Sun Yat-sen University (CN)
- St Petersburg University (RU)
- Shanghai Jiao Tong University (CN)
- XinHua Hospital (CN)
- First Affiliated Hospital of Guangzhou Medical University (CN)
- Institute of Transplantation Sciences (IN)
- Gujarat Kidney Foundation (IN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- Second Affiliated Hospital of Harbin Medical University (CN)
- Baoshan University (CN)
- Guizhou Provincial People's Hospital (CN)
- Nanjing Medical University (CN)
- China Medical University (CN)
- Guangzhou Medical University (CN)
Publication Details
- Journal
- European Urology Open Science
- Published
- 2024-11-04
- DOI
- https://doi.org/10.1016/j.euros.2024.10.014
- Citations
- 13
- Primary Topic
- Kidney Stones and Urolithiasis Treatments
- Type
- article
- Field-Weighted Citation Impact
- 5.45
Funders
- Guangzhou Medical University
- National Natural Science Foundation of China