TY - JOUR

T1 - Flexible Ureteroscopy with a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2–3 cm Renal Stones: An International, Multicenter, Randomized, Noninferiority Trial

AU - Zeng, Guohua

AU - Jiang, Kehua

AU - Liu, Shusheng

AU - Wu, Rongpei

AU - Duan, Xianzhong

AU - Chai, Chu Ann

AU - Gökce, Mehmet Ilker

AU - Гаджиев, Нариман Казиханович

AU - Kalathia, Jaisukh

AU - Wang, Kefeng

AU - Zhao, Enyang

AU - Song, Rijin

AU - Gauhar, Vineet

AU - Bai, Song

AU - Wang, Qing

AU - Zhu, Wei

AU - Cao, Jianwei

AU - Liu, Yongda

PY - 2025/6/17

Y1 - 2025/6/17

N2 - Background and objective: The efficacy and safety of flexible ureteroscopy (f-URS) using a flexible and navigable suction ureteral access sheath (FANS) versus mini-percutaneous nephrolithotomy (mPCNL) for 2–3 cm renal stones remain controversial. Our aim was to conduct a study to address the evidence gap. Methods: We conducted a multicenter, noninferiority, randomized controlled trial in which 720 patients were enrolled across 12 centers in China, Turkey, Russia, India, and Malaysia from August 2024 to February 2025. Patients with 2–3 cm stones were randomized 1:1 to FANS f-URS or mPCNL. The primary outcome was the immediate stone-free rate (SFR) (noninferiority margin −8%). Secondary outcomes included operative time, hospital stay, auxiliary procedures, 3-mo SFR, complications, and quality of life (QoL) improvement. Key findings and limitations: FANS f-URS was noninferior to mPCNL in terms of the immediate SFR (risk difference [RD] −1.4%, 95% confidence interval [CI] −6.7% to 3.9%; noninferiority 1-sided p = 0.007). FANS f-URS had a longer operative time (mean difference [MD] 29 min, 95% CI 24–33; p < 0.001), lower transfusion rate (RD −2.2%, 95% CI −3.9% to −0.5%; p = 0.021), shorter postoperative hospitalization (MD −2.5 d, 95% CI −2.8 to −2.2; p < 0.001), and a greater improvement in QoL score (MD 4.8, 95% CI 3.0–6.6; p < 0.001). We found no evidence of differences in auxiliary procedures, the 3-mo SFR, or infection-related complications. Conclusions and clinical implications: FANS f-URS had a noninferior SFR in comparison to mPCNL for 2–3 cm renal stones, with lower risk of bleeding risk, shorter hospitalization, and superior QoL. These findings support FANS f-URS as a viable alternative to mPCNL for 2–3 cm stones.

AB - Background and objective: The efficacy and safety of flexible ureteroscopy (f-URS) using a flexible and navigable suction ureteral access sheath (FANS) versus mini-percutaneous nephrolithotomy (mPCNL) for 2–3 cm renal stones remain controversial. Our aim was to conduct a study to address the evidence gap. Methods: We conducted a multicenter, noninferiority, randomized controlled trial in which 720 patients were enrolled across 12 centers in China, Turkey, Russia, India, and Malaysia from August 2024 to February 2025. Patients with 2–3 cm stones were randomized 1:1 to FANS f-URS or mPCNL. The primary outcome was the immediate stone-free rate (SFR) (noninferiority margin −8%). Secondary outcomes included operative time, hospital stay, auxiliary procedures, 3-mo SFR, complications, and quality of life (QoL) improvement. Key findings and limitations: FANS f-URS was noninferior to mPCNL in terms of the immediate SFR (risk difference [RD] −1.4%, 95% confidence interval [CI] −6.7% to 3.9%; noninferiority 1-sided p = 0.007). FANS f-URS had a longer operative time (mean difference [MD] 29 min, 95% CI 24–33; p < 0.001), lower transfusion rate (RD −2.2%, 95% CI −3.9% to −0.5%; p = 0.021), shorter postoperative hospitalization (MD −2.5 d, 95% CI −2.8 to −2.2; p < 0.001), and a greater improvement in QoL score (MD 4.8, 95% CI 3.0–6.6; p < 0.001). We found no evidence of differences in auxiliary procedures, the 3-mo SFR, or infection-related complications. Conclusions and clinical implications: FANS f-URS had a noninferior SFR in comparison to mPCNL for 2–3 cm renal stones, with lower risk of bleeding risk, shorter hospitalization, and superior QoL. These findings support FANS f-URS as a viable alternative to mPCNL for 2–3 cm stones.

KW - Flexible and navigable suction ureteral access sheath

KW - Flexible ureteroscopy

KW - Percutaneous nephrolithotomy

KW - Renal stones

UR - https://www.mendeley.com/catalogue/bc68ce3f-971f-3b82-92de-afd9368f8a7b/

U2 - 10.1016/j.eururo.2025.06.001

DO - 10.1016/j.eururo.2025.06.001

M3 - Article

JO - European Urology

JF - European Urology

SN - 0302-2838

ER -