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)
Year: 2025
Type: article
Study design: Study Protocol
Abstract: 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, non-inferiority 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. Trial registration: ClinicalTrials.gov NCT07159035.
Source: BJUI Compass
DOI: 10.1002/bco2.70114
Authors: Wei Zhu, Jinghua Zhong, Kefeng Wang, Guangming Yin, Chi‐Ho Leung, Nariman Gadzhiev, Mehmet Ilker Gökce, Jaisukh Kalathia, Vineet Gauhar, Guangyuan Zhang, Gang Wu, Mingyong Li, Li Fang, Shaohua Zeng, Peide Bai, Ji Li, Zhenhua Zhao, Ming Xi, Xin Mai, Xianzhong Duan, Kehua Jiang, Jianwei Cao, Xianghu Meng, Shusheng Liu, Aram Aloyan, Peng Yuan, Xiaorui Zhu, Ting Huang, Jianhui Xing, Jingzeng Du, Wenqi Wu, Jinxiang Ma, Wen Zhong, Zhijian Zhao, Yongda Liu, Chi Fai Ng, Jean de la Rosette, Bhaskar Somani, Shiyong Qi, Guohua Zeng, Steffi Kar Kei Yuen
Institutions: First Affiliated Hospital of Guangzhou Medical University, Sheng Jing Hospital, China Medical University, Central South University, Third Xiangya Hospital, Chinese University of Hong Kong, St Petersburg University, Ankara University, Ng Teng Fong General Hospital, Zhongda Hospital Southeast University, Southeast University, Tongji University, First Affiliated Hospital of University of South China, University of South China, Ningbo University, Ningbo University Affiliated Hospital, Ningbo First Hospital, Guangzhou Medical University, Xiamen University, First Affiliated Hospital of Xiamen University, South China University of Technology, Jiangmen Central Hospital, Jiangsu Province Hospital, Nanjing Medical University, Guizhou Provincial People's Hospital, Shanghai Jiao Tong University, XinHua Hospital, Second Affiliated Hospital of Guangzhou Medical University, Istanbul Medipol University, Bashkir State Medical University, University Hospital Southampton NHS Foundation Trust, Second Hospital of Tianjin Medical University, Tianjin Medical University
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,770
OpenAlex ID: W4416813393