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

January 9, 2026 updated by: Shereef almegabar, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11511
        • Ain Shams University Hospitals (Urology Department)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supine Mini Percutaneous Nephrolithotomy
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
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.
Active Comparator: Flexible Ureteroscopy
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
Retrograde endoscopic access to the kidney using a flexible ureteroscope with laser lithotripsy for stone fragmentation, followed by ureteral stent placement per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: Intraoperative
Total operative time for the assigned procedure (in minutes).
Intraoperative
Fluoroscopy Time
Time Frame: Intraoperative
Total fluoroscopy time used during the procedure (in seconds or minutes, per recorded operating room log).
Intraoperative
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.
From end of procedure (day of surgery) until hospital discharge, assessed up to 30 days.
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.
Up to 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

June 15, 2025

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU_MS814_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data related to the primary and secondary outcomes (including demographics, baseline stone characteristics such as stone size and density, assigned intervention, operative variables, postoperative imaging results, complications, and follow-up outcomes) will be made available to qualified researchers to enable verification of results and secondary analyses. Direct identifiers will be removed, and data will be coded prior to sharing.

IPD Sharing Time Frame

Data will be available beginning 6 months after study completion and will remain available for 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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