%0 Article
%A Wei Zhu, 
%A Jinghua Zhong, 
%A Kefeng Wang, 
%A Guangming Yin, 
%A Chi-Ho Leung, 
%A Nariman Gadzhiev, 
%A Mehmet Ilker Gökce, 
%A Jaisukh Kalathia, 
%A Vineet Gauhar, 
%A Guangyuan Zhang, 
%A Gang Wu, 
%A Mingyong Li, 
%A Li Fang, 
%A Shaohua Zeng, 
%A Peide Bai, 
%A Ji Li, 
%A Zhenhua Zhao, 
%A Ming Xi, 
%A Xin Mai, 
%A Xianzhong Duan, 
%A Kehua Jiang, 
%A Jianwei Cao, 
%A Xianghu Meng, 
%A Shusheng Liu, 
%A Aram Aloyan, 
%A Peng Yuan, 
%A Xiaorui Zhu, 
%A Ting Huang, 
%A Jianhui Xing, 
%A Jingzeng Du, 
%A Wenqi Wu, 
%A Jinxiang Ma, 
%A Wen Zhong, 
%A Zhijian Zhao, 
%A Yongda Liu, 
%A Chi Fai Ng, 
%A Jean de la Rosette, 
%A Bhaskar Somani, 
%A Shiyong Qi, 
%A Guohua Zeng, 
%A Steffi Kar Kei Yuen, 
%T 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)
%D 2025
%R 10.1002/bco2.70114
%J BJUI COMPASS
%X 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.
%U https://repo.bashgmu.ru/publication/5409