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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07322471
Enrollment
138
Registered
2026-01-07
Start date
2026-01-01
Completion date
2026-07-01
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stones

Keywords

PCNL, RIRS, staghorn stone, renal stone

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.

Interventions

PROCEDUREPercutaneous nephrolithotomy

This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone

This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stone free rate1 MonthStone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.

Secondary

MeasureTime frameDescription
Operative timeDuring the surgeryOperative time is defined as time between starting the procedure and termination of it measured in minutes
Complications1 monthIntra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification
Radiation timeDuring the surgeryRadiation time, defined as time in which ionizing radiation used intraoperatively, measured in minutes

Countries

Egypt

Contacts

Primary ContactAmmar Alorabi
ammar.alorabi95@gmail.com+201067608011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026