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

ConditionsStone, Kidney Stone, Urinary

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

FANS-Based Flexible Ureteroscopy (FURS)
Procedure/Surgery
Under general/ spinal anesthesia, patients will be placed in lithotomy position. After guidewire placement, a flexible navigable suction ureteral access sheath (FANS) will be advanced to the renal pelvis. Lithotripsy will be performed using a digital flexible ureteroscope and holmium laser with optimized settings for dusting and fragmentation. Continuous irrigation combined with active suction will enhance visualization and fragment clearance. A double-J stent will be placed post-procedure.
Suction-Assisted Mini-PCNL
Procedure/Surgery
Under general or spinal anesthesia, patients will be placed in the prone position. Percutaneous renal access will be achieved under ultrasound or fluoroscopy guidance using an 18G puncture needle. Tract dilation will be performed up to 16-22 Fr, followed by the insertion of a suction-enabled miniaturized sheath (e.g., ClearPetra or equivalent). A mini-nephroscope will be introduced to visualize and fragment stones using Holmium:YAG fiber laser. Continuous irrigation combined with active negative-pressure suction through the access sheath will facilitate real-time removal of stone dust and fragments while maintaining low intrarenal pressure and clear visualization. A nephrostomy tube or double-J stent will be inserted at the surgeon's discretion.

Treatment groups

254 Participants

are divided into 2 treatment groups

Group A: FANS-Based Flexible Ureteroscopy (FURS)Experimental treatment 1 intervention

Group B: Suction-Assisted Mini-PCNLActive comparator 1 intervention

Trial outcomes

Primary outcomes

stone-free rate (SFR) at 1 month postoperatively

. SFR will be evaluated using a spiral non-contrast computed tomography (NCCT) scan performed at 1 month after the procedure. Stone-free status will be categorized as no residual or with residual fragments

Time frame

1 month postoperatively

Sponsors and contacts

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Mansoura University

Lead sponsor

Source ClinicalTrials.gov

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