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

A Multicenter Randomized Trial Comparing FANS-Based Flexible Ureteroscopy Versus Suction Mini-Percutaneous Nephrolithotomy for Renal Stones 2-3 cm. The National Innovative Large Egyptian (NILE) Stone Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stone, Kidney; Stone, Urinary
• Intervention / Treatment: Procedure: FANS-Based Flexible Ureteroscopy (FURS); Procedure: Suction-Assisted Mini-PCNL

Detailed Description

Aim of the Study

The primary aim of this study is to compare the stone-free rate (SFR) of FANS-assisted flexible ureteroscopy versus suction-assisted mini-percutaneous nephrolithotomy (mini-PCNL) in patients with renal stones measuring 2 to 3 cm. Secondary aims include comparing perioperative outcomes, complication rates, length of hospital stay, and patient-reported quality of life between the two treatment modalities.

Patients and Methods Study Design

This is a prospective, multicenter, randomized, superiority trial. Patients will be recruited from nine high-volume tertiary referral centers. Participants will be randomized in a 1:1ratio to undergo either FANS-based flexible ureteroscopy or suction mini-PCNL using a computer-generated randomization tables, stratified by each center. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE) prepared by an independent person who is not involved in patients' recruitment or treatment. Surgeons and investigators will be blinded to group allocation until the point of intervention.

Ethical Considerations The study protocol will be approved by the Institutional Review Board (IRB) of each participating center. All patients will provide written informed consent before enrollment. The study will be conducted in accordance with the principles of the Declaration of Helsinki.

Patient Evaluation and Recruitment All patients will undergo a standardized preoperative assessment including medical history, physical examination, blood tests (CBC, renal function, coagulation profile), urinalysis, urine culture, and non-contrast CT (NCCT) for stone size, density (HU), and volume assessment. Eligible patients will be screened and enrolled after providing informed consent. Antibiotic prophylaxis will be administered according to European Association of Urology (EAU) guidelines.

• Study Type: Interventional
• Enrollment (Estimated): 254
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud AN Laymon, A.Prof.; Phone Number: 066053151; Email: dr_mahmoudlaymon@mans.edu.eg
• Study Contact Backup: Name: Ahmed Shokeir, Prof; Email: ahmed.shokeir@hotmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University
    • Contact: Amr Elgebaly
  • Asyut, Egypt
    • Assuit university
  • Cairo, Egypt
    • Cairo University
    • Contact: Amr Elkady
  • Cairo, Egypt
    • Ain Shams University
  • Minya, Egypt
    • Minya University
  • Shibīn al Kawm, Egypt
    • Menoufia University
    • Contact: Mohamed Elshazly
  • Tanta, Egypt
    • Tanta University
    • Contact: Maged Ragab
  • Zagazig, Egypt
    • Zagazig University
  • Outside U.S./Canada
    • Al Mansurah, Outside U.S./Canada, Egypt, 35516
      • Urology and nephrology center
      • Contact: Mahmoud AN Laymon; Phone Number: 066053151; Email: dr_mahmoudlaymon@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Signed informed consent.

Exclusion Criteria:

• Active urinary tract infection.
• Anomalous renal anatomy (e.g., horseshoe kidney).
• Severe ureteral strictures preventing retrograde access.
• Coagulopathy or inability to discontinue anticoagulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FANS-Based Flexible Ureteroscopy (FURS)	Procedure: FANS-Based Flexible Ureteroscopy (FURS); 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.
Active Comparator: Suction-Assisted Mini-PCNL	Procedure: Suction-Assisted Mini-PCNL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Urolithiasis; RIRS; Nephrolithiasis; Renal stones; mini-PCNL; FANS; Stone-free rate; Suction technology
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Nephrolithiasis; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: NILE Stone Study; RP.25.8.1033 (Other Identifier: Faculty of medicine, Mansoura University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No