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NCT Number: NCT07322471

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

percutaneous nephrolithotomy

Procedure

This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone

flexible ureteroscopy

Procedure

This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

Primary outcomes

  1. Stone free rate

    Time frame: 1 Month

    Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.

Secondary outcomes

  1. Operative time

    Time frame: During the surgery

    Operative time is defined as time between starting the procedure and termination of it measured in minutes

  2. Complications

    Time frame: 1 month

    Intra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification

  3. Radiation time

    Time frame: During the surgery

    Radiation time, defined as time in which ionizing radiation used intraoperatively, measured in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Ammar Alorabi

CONTACT

[email protected]

+201067608011

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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