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

NCT ID: NCT07322471

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCNL group

patients of this group will undergo percutanous nephrolithotomy

Group Type: ACTIVE_COMPARATOR

Percutaneous nephrolithotomy

Intervention Type: PROCEDURE

This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone

FURS group

Patients of this group will undergo flexible ureteroscopy

Group Type: ACTIVE_COMPARATOR

Flexible ureteroscopy

Intervention Type: PROCEDURE

This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

Interventions

Percutaneous nephrolithotomy

This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone

Intervention Type: PROCEDURE

Flexible ureteroscopy

This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Ammar Fathi Mohamed AlOrabi

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, Egypt

Countries

Egypt

Central Contacts

Ammar Alorabi

Role: CONTACT

ammar.alorabi95@gmail.com

+201067608011

Facility Contacts

Baher Salman

Role: primary

Bahersalman@yahoo.com

+201069973254

Other Identifiers

PCNL vs FURS in staghorn stone

Identifier Type: -

Identifier Source: org_study_id