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Completed

NCT Number: NCT07345234

Comparison Between Supine Mini-PCNL and Flexible Ureteroscopy (FURS) for Dense Lower Calyceal Stones (1-2 cm) in School-Age Pediatric Patients

This randomized controlled clinical study compared supine mini percutaneous nephrolithotomy versus flexible ureteroscopy for the management of dense lower calyceal renal stones measuring 1-2 centimeters (≤20 millimeters) with stone density greater than 1000 Hounsfield units in school-age pediatric patients aged 6-12 years. Participants were randomized to undergo either supine mini percutaneous nephrolithotomy with laser lithotripsy or flexible ureteroscopy with laser lithotripsy. The study assessed stone-free rate on non-contrast computed tomography of the urinary tract at 1 month postoperatively, along with operative time, fluoroscopy time, intraoperative and postoperative complications, and length of hospital stay. The trial has ended.

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Key information

Conditions

Nephrolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals (Urology Department)

Cairo, Cairo Governorate, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 6 to 12 years
  • Single lower calyceal renal stone measuring 1-2 centimeters (≤20 millimeters) with stone density greater than 1000 Hounsfield units
  • No previous urological surgery that could distort the pelvicalyceal system

Exclusion criteria

  • Additional ureteral stones and/or congenital renal anomalies (for example, horseshoe kidney or pelviureteric junction obstruction)
  • Multiple renal stones
  • Untreated urinary tract infection (temporarily excluded until treated)

Treatment and study plan

Supine Mini Percutaneous Nephrolithotomy

Procedure

Percutaneous renal access and tract dilation to mini size in the supine position, followed by endoscopic stone fragmentation using laser lithotripsy, with ureteral stent placement and nephrostomy tube placement per protocol.

flexible ureteroscopy

Procedure

Retrograde endoscopic access to the kidney using a flexible ureteroscope with laser lithotripsy for stone fragmentation, followed by ureteral stent placement per protocol.

Primary outcomes

  1. Stone-Free Rate

    Time frame: 1 month postoperatively

    Proportion of participants who were stone-free on non-contrast computed tomography of the urinary tract at 1 month after the procedure. Clinically insignificant residual fragments were defined as asymptomatic residual stones smaller than 2 millimeters.

Secondary outcomes

  1. Operative Time

    Time frame: Intraoperative

    Total operative time for the assigned procedure (in minutes).

  2. Fluoroscopy Time

    Time frame: Intraoperative

    Total fluoroscopy time used during the procedure (in seconds or minutes, per recorded operating room log).

  3. Length of Hospital Stay

    Time frame: From end of procedure (day of surgery) until hospital discharge, assessed up to 30 days.

    Duration of postoperative hospital stay (in days) following the procedure.

  4. Intraoperative and Postoperative Complications

    Time frame: Up to 3 months postoperatively

    Frequency and type of complications occurring intraoperatively and during follow-up after the procedure.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison Between Supine Mini Percutaneous Nephrolithotomy (PCNL) and Flexible Ureteroscopy (FURS) in Management of Lower Calyceal Stones 1-2 Centimeters With More Than 1000 Hounsfield Unit in School-Age Pediatric Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 15, 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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