NephrolithiasisNCT07345234
Comparison Between Supine Mini-PCNL and Flexible Ureteroscopy (FURS) for Dense Lower Calyceal Stones (1-2 cm) in School-Age Pediatric Patients
A study testing Supine Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy in people with Nephrolithiasis and Kidney Calculi, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Nephrolithiasis, Kidney Calculi, Urolithiasis
- What is being tested?
- Supine Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Hospitals (Urology Department)
Cairo, Cairo Governorate, 11511
About this study
Official 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
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
- Being tested
- Supine Mini Percutaneous Nephrolithotomy, Flexible Ureteroscopy
- Keywords
- pediatric, children, school-age, lower calyx, lower pole, renal stone, kidney stone, flexible ureteroscopy, high-density stone, mini percutaneous nephrolithotomy, laser lithotripsy
- Medical subject headings
- Nephrolithiasis, Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine Mini Percutaneous NephrolithotomyProcedure or surgery
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 UreteroscopyProcedure or surgery
Retrograde endoscopic access to the kidney using a flexible ureteroscope with laser lithotripsy for stone fragmentation, followed by ureteral stent placement per protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month postoperatively
Secondary outcomes (4)
Operative Time
Total operative time for the assigned procedure (in minutes).
Measured: Intraoperative
Fluoroscopy Time
Total fluoroscopy time used during the procedure (in seconds or minutes, per recorded operating room log).
Measured: Intraoperative
Length of Hospital Stay
Duration of postoperative hospital stay (in days) following the procedure.
Measured: From end of procedure (day of surgery) until hospital discharge, assessed up to 30 days.
Intraoperative and Postoperative Complications
Frequency and type of complications occurring intraoperatively and during follow-up after the procedure.
Measured: Up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jan 2025
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereef almegabar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345234
- Sponsor's protocol ID
- FMASU_MS814_2025
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07345234
- Acronym / sponsor ID
- FMASU_MS814_2025
- Conditions
- Nephrolithiasis, Kidney Calculi, Urolithiasis
- Keywords
- pediatric, children, school-age, lower calyx, lower pole, renal stone, kidney stone, flexible ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supine Mini Percutaneous Nephrolithotomy | Active comparator | Procedure: Supine Mini Percutaneous NephrolithotomyParticipants 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. |
| Flexible Ureteroscopy | Active comparator | Procedure: Flexible UreteroscopyParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine Mini Percutaneous NephrolithotomyPercutaneous 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. | Procedure or surgery | Supine Mini Percutaneous Nephrolithotomy |
| Flexible UreteroscopyRetrograde endoscopic access to the kidney using a flexible ureteroscope with laser lithotripsy for stone fragmentation, followed by ureteral stent placement per protocol. | Procedure or surgery | Flexible Ureteroscopy |
Primary outcome
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.
4 secondary outcomes
Operative Time
Time frame: Intraoperative
Fluoroscopy Time
Time frame: Intraoperative
Length of Hospital Stay
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy in people with Nephrolithiasis and Kidney Calculi, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.