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

Ain Shams University

Status: Completed

Conditions: Urolithiasis; Kidney Calculi; Nephrolithiasis

Treatments: Procedure: Supine Mini Percutaneous Nephrolithotomy; Procedure: Flexible Ureteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07345234

FMASU_MS814_2025

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Supine Mini Percutaneous Nephrolithotomy

Active Comparator group

Description:

Participants underwent supine mini percutaneous nephrolithotomy for lower calyceal renal stones. A ureteral catheter was placed cystoscopically, renal access was obtained under fluoroscopic guidance with an 18-gauge needle, a guidewire was inserted, and tract dilation was performed up to 16 French followed by placement of a renal access sheath. Stones were fragmented using laser lithotripsy via a mini nephroscope. A double-J ureteral stent was placed, and a nephrostomy tube was left in place per protocol.

Treatment:

Procedure: Supine Mini Percutaneous Nephrolithotomy

Flexible Ureteroscopy

Active Comparator group

Description:

Participants underwent flexible ureteroscopy in the dorsal lithotomy position. After cystoscopy, a guidewire was advanced into the renal pelvis under fluoroscopic guidance. A digital flexible ureteroscope was used to access the kidney and visualize the stone. Stone fragmentation was performed using laser lithotripsy (dusting technique per protocol). A double-J ureteral stent was placed and scheduled for removal approximately 3 to 4 weeks after the procedure.

Treatment:

Procedure: Flexible Ureteroscopy