Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones

Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial

Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. However, PCNL is a challenging procedure which may be associated with several complications ranging from mild complications, such as urinary extravasation, leakage, infection and bleeding requiring transfusion to sever complications, such as sepsis, injury to surrounding organs, persistent hematuria and renal function impairment. The overall complication rate varies based on patient factors and surgical expertise.

Not only serious complications that defer some endourologists from performing PCNL but also such procedure is contraindicated and avoided by surgeons in cases of retrorenal colon, morbidly obese patients, spinal abnormalities and bleeding diathesis. Therefore, retrograde intrarenal surgery (RIRS) or flexible ureteroscopy (FURS) is increasingly recognized as an effective alternative, particularly for patients seeking a minimally invasive approach with a lower risk of complications.

The best practice in dealing with renal stones using FURS can be achieved via preoperative stenting for 2-4 weeks, negative urine culture, ureteral access sheath (UAS) usage and optimizing laser settings. Compared to PCNL, FURS is a less challenging procedure with low learning curve, less invasive and less bleeding. However, the high cost, including laser usage cost, presenting costs and multisession costs, in addition to the high risk of postoperative infection are considered as major drawbacks of FURS.

RIRS is emerging as an effective, safe, minimally invasive alternative to PCNL. Yet, the success of RIRS in comparison to PCNL, especially in a single session, is still questionable and there is no consensus about it.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Stones
• Intervention / Treatment: Procedure: Percutaneous nephrolithotomy; Procedure: Flexible ureteroscopy

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ammar Alorabi; Phone Number: +201067608011; Email: ammar.alorabi95@gmail.com

Study Locations

• Egypt
  • Menoufia
    • Shebin El-Kom, Menoufia, Egypt, 32511
      • Menoufia Faculty of Medicine
      • Contact: Baher Salman; Phone Number: +201069973254; Email: Bahersalman@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged ≥18 years.
• Diagnosis of complete staghorn renal stones confirmed by non-contrast CT.
• Negative urine culture.

Exclusion Criteria:

• Congenital renal anomalies (e.g., horseshoe kidney, malrotation).
• Coagulopathy or uncorrected bleeding disorder.
• Pregnancy.
• Previous ipsilateral renal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCNL group; patients of this group will undergo percutanous nephrolithotomy	Procedure: Percutaneous nephrolithotomy; This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone
Active Comparator: FURS group; Patients of this group will undergo flexible ureteroscopy	Procedure: Flexible ureteroscopy; This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.	1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Intra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification	1 month
Operative time	Operative time is defined as time between starting the procedure and termination of it measured in minutes	During the surgery
Radiation time	Radiation time, defined as time in which ionizing radiation used intraoperatively, measured in minutes	During the surgery

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: RIRS; PCNL; renal stone; staghorn stone
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Nephrolithiasis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endoscopy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Laparoscopy; Nephrolithotomy, Percutaneous
• Other Study ID Numbers: PCNL vs FURS in staghorn stone

Drug and device information, study documents

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