FANS-FURS vs Suction Mini-PCNL for 2-3 cm Renal Stones: A Multicenter Randomized Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

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

Treatment groups

254 Participants
are divided into 2 treatment groups

Sponsors and collaborators