Clinical Trial

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

Study acronym: NILE
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-08.
Trial Details
NCT Number NCT07295860
Lead Sponsor Mansoura University
Conditions Stone, Kidney, Stone, Urinary
Enrollment 254 participants
Start Date 2026-01-01
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-26