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Recruiting Not applicable

Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones

NCT07753733 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-08-13
Last updated
2026-09-01

Condition(s) studied

Percutaneous Nephrolithotomy

Investigational drug(s) / intervention(s)

Flexible Nephroscopy-Assisted Single-Tract PCNLConventional Multi-Tract PCNL

Flexible Nephroscopy-Assisted Single-Tract PCNL: Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.

Conventional Multi-Tract PCNL: Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

Study summary

This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-70 years. Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT. Preoperative expectation of multiple accesses by the surgeon. Written informed consent. Exclusion Criteria: Solitary kidney. Uncorrected coagulopathy. Active urinary tract infection. ASA grade IV or higher. Pregnancy. Previous ipsilateral PCNL or open renal surgery. Stones less than 2 cm or simple calyceal stones. Refusal or inability to comply with follow-up. \-

Primary outcome measure(s)

  • Stone-free rate at 3 months. — 3 months after surgery.
    Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753733 on ClinicalTrials.gov ↗ ← All trials in Egypt