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

NCT07322471 | Not Yet Recruiting

• 1 other identifier: PCNL vs FURS in staghorn stone
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Stones

Keywords

PCNL; RIRS; staghorn stone; renal stone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Operative time

  During the surgery

• Complications

  1 month

• Radiation time

  During the surgery

Study Arms (2)

PCNL group

ACTIVE COMPARATOR

patients of this group will undergo percutanous nephrolithotomy

Procedure: Percutaneous nephrolithotomy

FURS group

ACTIVE COMPARATOR

Patients of this group will undergo flexible ureteroscopy

Procedure: Flexible ureteroscopy

Interventions

Percutaneous nephrolithotomy PROCEDURE

This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone

PCNL group

Flexible ureteroscopy PROCEDURE

This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

FURS group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Ammar Alorabi

CONTACT

+201067608011; ammar.alorabi95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

EG (1)