RT - Article
SR - Electronic
T1 - Flexible ureteroscopy with a flexible and navigable suction ureteral access sheath versus mini-percutaneous nephrolithotomy for 1–2 cm lower pole renal stones: Protocol for an international, multicentre, randomized non-inferiority trial (FLAME trial)
JF - BJUI COMPASS
SP - 2026-05-24
DO - 10.1002/bco2.70114
A1 - Wei Zhu, 
A1 - Jinghua Zhong, 
A1 - Kefeng Wang, 
A1 - Guangming Yin, 
A1 - Chi-Ho Leung, 
A1 - Nariman Gadzhiev, 
A1 - Mehmet Ilker Gökce, 
A1 - Jaisukh Kalathia, 
A1 - Vineet Gauhar, 
A1 - Guangyuan Zhang, 
A1 - Gang Wu, 
A1 - Mingyong Li, 
A1 - Li Fang, 
A1 - Shaohua Zeng, 
A1 - Peide Bai, 
A1 - Ji Li, 
A1 - Zhenhua Zhao, 
A1 - Ming Xi, 
A1 - Xin Mai, 
A1 - Xianzhong Duan, 
A1 - Kehua Jiang, 
A1 - Jianwei Cao, 
A1 - Xianghu Meng, 
A1 - Shusheng Liu, 
A1 - Aram Aloyan, 
A1 - Peng Yuan, 
A1 - Xiaorui Zhu, 
A1 - Ting Huang, 
A1 - Jianhui Xing, 
A1 - Jingzeng Du, 
A1 - Wenqi Wu, 
A1 - Jinxiang Ma, 
A1 - Wen Zhong, 
A1 - Zhijian Zhao, 
A1 - Yongda Liu, 
A1 - Chi Fai Ng, 
A1 - Jean de la Rosette, 
A1 - Bhaskar Somani, 
A1 - Shiyong Qi, 
A1 - Guohua Zeng, 
A1 - Steffi Kar Kei Yuen, 
YR - 2025
UL - https://repo.bashgmu.ru/publication/5409
AB - Background: Lower pole renal stones measuring 1–2 cm remain challenging to treat.
While mini-percutaneous nephrolithotomy (mini-PCNL) provides high stone-free
rates (SFRs), it carries tract-related morbidity. Flexible ureteroscopy (f-URS) is less
invasive but limited in SFR. The flexible and navigable suction ureteral access sheath
(FANS) has shown promise in improving stone evacuation and intrarenal pressure
control. We hypothesize that FANS f-URS is non-inferior to mini-PCNL for patients
with 1–2 cm lower pole stones in SFR.
Study Design: The FLAME trial is an international, multicentre, randomized, noninferiority study directly comparing FANS-f-URS with mini-PCNL in this setting. Endpoints: The primary outcome is immediate SFR within 72 hours on low-dose
CT. Secondary outcomes include SFR at 1 month, operative time, postoperative pain,
hospital stay, complications (Clavien–Dindo) and quality-of-life changes.
Patients and Methods: A total of 640 adults with CT-confirmed 1–2 cm lower pole
renal stones will be randomized 1:1 to undergo FANS-f-URS or mini-PCNL across
20 high-volume urology centres worldwide. Randomization is centralized and stratified by site. Radiologists and statisticians will remain blinded to allocation. Sample
size was calculated assuming an 85% SFR for both arms, an 8.5% non-inferiority margin, 80% power and 15% attrition. Analyses will follow both intention-to-treat and
per-protocol principles.