About this trial
This multicenter, prospective, randomized clinical trial compares FANS-assisted flexible ureteroscopy (FURS) with suction-assisted mini-percutaneous nephrolithotomy (mini-PCNL) for the treatment of renal stones measuring 2-3 cm. A total of 280 patients will be enrolled across nine tertiary centers and randomized 1:1 to either technique. The primary endpoint is stone-free rate (SFR) at 1 month, assessed by non-contrast CT. Secondary outcomes include operative time, intraoperative complications, postoperative morbidity (Clavien-Dindo), pain scores, hospital stay, reinterventions, and quality of life (EQ-5D-5L). The study aims to provide the first high-quality head-to-head evidence comparing these two modern suction-enhanced technologies, with the goal of defining the optimal minimally invasive approach for medium-sized renal stones.
Eligibility criteria
Qualifiers
Adults ≥18 years old.
Single or multiple renal stones measuring 2 -3 cm (diagnosed by NCCT).
Negative urine culture prior to surgery.
Suitable for general/spinal anesthesia.
Disqualifiers
Active urinary tract infection.
Anomalous renal anatomy (e.g., horseshoe kidney).
Severe ureteral strictures preventing retrograde access.
Coagulopathy or inability to discontinue anticoagulation.
Trial design
Treatments tested in this trial
- FANS-Based Flexible Ureteroscopy (FURS)
- Suction-Assisted Mini-PCNL