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

NCT ID: NCT07295860

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-03-01

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.

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.

Conditions

Stone, Kidney; Stone, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FANS-Based Flexible Ureteroscopy (FURS)

Group Type: EXPERIMENTAL

FANS-Based Flexible Ureteroscopy (FURS)

Intervention Type: 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.

Suction-Assisted Mini-PCNL

Group Type: ACTIVE_COMPARATOR

Suction-Assisted Mini-PCNL

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Urology and nephrology center

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

Alexandria University

Alexandria, , Egypt

Assuit University

Asyut, , Egypt

Ain Shams University

Cairo, , Egypt

Cairo university

Cairo, , Egypt

Minya University

Minya, , Egypt

Menoufia University

Shibīn al Kawm, , Egypt

Tanta University

Tanta, , Egypt

Zagazig university

Zagazig, , Egypt

Countries

Egypt

Central Contacts

Mahmoud AN Laymon, A.Prof.

Role: CONTACT

dr_mahmoudlaymon@mans.edu.eg

066053151

Ahmed Shokeir, Prof

Role: CONTACT

ahmed.shokeir@hotmail.com

Facility Contacts

Mahmoud AN Laymon

Role: primary

dr_mahmoudlaymon@mans.edu.eg

066053151

Amr Elgebaly

Role: primary

Amr Elkady

Role: primary

Mohamed Elshazly

Role: primary

Maged Ragab

Role: primary

Other Identifiers

RP.25.8.1033

Identifier Type: OTHER

Identifier Source: secondary_id

NILE Stone Study

Identifier Type: -

Identifier Source: org_study_id