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

NCT07295860 | Not Yet Recruiting DMC

• 2 other identifiers: NILE Stone StudyRP.25.8.1033
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Stone, Urinary; Stone, Kidney

Keywords

Renal stones; Nephrolithiasis; Urolithiasis; RIRS; FANS; mini-PCNL; Suction technology; Stone-free rate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

FANS-Based Flexible Ureteroscopy (FURS)

EXPERIMENTAL

Procedure: FANS-Based Flexible Ureteroscopy (FURS)

Suction-Assisted Mini-PCNL

ACTIVE COMPARATOR

Procedure: Suction-Assisted Mini-PCNL

Interventions

Suction-Assisted Mini-PCNL PROCEDURE

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.

Suction-Assisted Mini-PCNL

FANS-Based Flexible Ureteroscopy (FURS) PROCEDURE

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.

FANS-Based Flexible Ureteroscopy (FURS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (9)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

Alexandria University

Alexandria, Egypt

Location

Assuit University

Asyut, Egypt

Location

Ain Shams University

Cairo, Egypt

Location

Cairo university

Cairo, Egypt

Location

Minya University

Minya, Egypt

Location

Menoufia University

Shibīn al Kawm, Egypt

Location

Tanta University

Tanta, Egypt

Location

Zagazig university

Zagazig, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi; Urinary Calculi; Nephrolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mahmoud AN Laymon, A.Prof.

CONTACT

066053151; dr_mahmoudlaymon@mans.edu.eg

Ahmed Shokeir, Prof

CONTACT

ahmed.shokeir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and surgeons are unblinded due to the nature of surgical interventions. However, postoperative imaging and clinical outcome assessment will be performed by blinded independent assessors."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

EG (9)