F‐
URS
with
FANS
versus
mPCNL
for 2–3 cm
UUTS
Rui Wang, Xingwang Qi, Chunpeng Li, Junkai Huang, Linguo Xie, Liwei Liu, Haijie Xie, Chunyu Liu Objective
To evaluate the safety and efficacy of flexible ureteroscopy (f‐URS) with a flexible and navigable suction ureteral access sheath (FANS) compared with mini‐percutaneous nephrolithotomy (mPCNL) in the treatment of 2–3 cm upper urinary tract stones (UUTS), with a prespecified subgroup analysis for stones ≥2 to <2.5 cm.
Methods
This randomized controlled trial enrolled 326 patients with 2–3 cm UUTS between June 2023 and December 2025. Patients were randomly assigned in a 1:1 ratio to undergo either f‐URS with FANS or mPCNL. A prespecified subgroup analysis was conducted for stones measuring ≥2 to <2.5 cm. The primary outcomes were the immediate and 1‐month stone‐free rate (SFR). Secondary outcomes included the operative duration, decrease in haemoglobin, hospital stay, and complication rate.
Results
The baseline characteristics were comparable between the two groups. In the overall 2–3 cm cohort, the FANS group achieved immediate and 1‐month SFRs comparable to those of the mPCNL group. Although the operative time was longer in the FANS group, it was associated with significantly less haemoglobin loss and a shorter hospital stay, with no significant difference in infection‐related complications. Notably, in the subgroup of stones ≥2 to <2.5 cm, the FANS group demonstrated a non‐inferior SFR at both time points, and the operative time was not significantly longer than that of the mPCNL group.
Conclusion
For 2–3 cm UUTS, f‐URS with FANS offers a SFR comparable to that of mPCNL, along with the advantages of reduced blood loss and shorter hospitalization. In the ≥2 to <2.5 cm subgroup, FANS shows comprehensive benefits over mPCNL. These findings support FANS as an effective alternative to mPCNL for 2–3 cm stones and a potentially preferred option for stones measuring 2–2.5 cm.