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

NCT07345234 | Completed

• 1 other identifier: FMASU_MS814_2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrolithiasis; Kidney Calculi; Urolithiasis

Keywords

pediatric; children; school-age; lower calyx; lower pole; renal stone; kidney stone; flexible ureteroscopy; high-density stone; mini percutaneous nephrolithotomy; laser lithotripsy

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate

  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.

  1 month postoperatively

Secondary Outcomes (4)

• Operative Time

  Intraoperative

• Fluoroscopy Time

  Intraoperative

• Length of Hospital Stay

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

• Intraoperative and Postoperative Complications

  Up to 3 months postoperatively

Study Arms (2)

Supine Mini Percutaneous Nephrolithotomy

ACTIVE COMPARATOR

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.

Procedure: Supine Mini Percutaneous Nephrolithotomy

Flexible Ureteroscopy

ACTIVE COMPARATOR

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.

Procedure: Flexible Ureteroscopy

Interventions

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.

Supine Mini Percutaneous Nephrolithotomy

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.

Flexible Ureteroscopy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals (Urology Department)

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study; participants and treating clinicians were aware of the assigned procedure. Outcome assessment was based on postoperative imaging and clinical follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Participants were randomly assigned to one of two parallel groups to undergo either supine mini percutaneous nephrolithotomy with laser lithotripsy or flexible ureteroscopy with laser lithotripsy for management of dense lower calyceal renal stones.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 15, 2026
• Study Start: January 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after study completion and will remain available for 5 years.
• Access Criteria: Access will be provided upon reasonable request for research purposes. Requests must include a brief proposal and analysis plan, and investigators must agree to a data use agreement specifying: use of de-identified data only, no attempts at re-identification, no redistribution to third parties, and appropriate citation of the study. Requests should be submitted to the study team at Ain Shams University Hospitals (Urology Department) using the contact information listed in the record.

Locations

EG (1)