Mini Percutaneous NephrolithotomyNCT07836192
Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)
A study testing Mini percutaneous nephrolithotomy and Flexible ureteroscopy in people with Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
This work aimed to compare the safety and efficacy of retrograde intrarenal surgery using single-use flexible ureteroscopy (FURS) with mini-percutaneous nephrolithotomy (PCNL) in children with renal stones measuring 10-30 mm. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Mini Percutaneous Nephrolithotomy, Retrograde Intrarenal Surgery, Pediatric
- What is being tested?
- 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
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Aug 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children <18 years old.
- Both sexes.
- Single calyceal renal stone of 10-20 mm in maximum diameter, single renal pelvic stone of 10-20 in maximum diameter with history of failed, extracorporeal shock wave lithotripsy (ESWL) or refused ESWL, single renal stone 20-30 mm in maximum diameter and multiple renal stones with total stone size 10-30 mm (sum of maximum dimensions of each stone).
Who cannot join
- Patients with uncorrected coagulopathy.
- Renal or ureteral malformation.
- Cases with significant anatomical obstruction requiring separate intervention or associated metabolic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison of Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)
This work aimed to compare the safety and efficacy of retrograde intrarenal surgery using single-use flexible ureteroscopy (FURS) with mini-percutaneous nephrolithotomy (PCNL) in children with renal stones measuring 10-30 mm.
Read the detailed description
Children have a smaller pelvicalyceal system, more delicate tissues, and a more curved ureter compared to adults.
While percutaneous nephrolithotomy (PCNL) offers excellent stone-free rates for large stones (>2 cm), its application in children presents challenges due to their smaller renal anatomy and increased kidney mobility.
Retrograde intrarenal surgery with flexible ureteroscopy (FURS) major advantage lies in utilizing natural orifices, eliminating the need for additional access routes with theoretically enhanced faster postoperative recovery.
- Being tested
- Mini percutaneous nephrolithotomy, Flexible ureteroscopy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini percutaneous nephrolithotomyProcedure or surgery
Patients underwent mini percutaneous nephrolithotomy (PCNL) technique.
Flexible ureteroscopyProcedure or surgery
Patients underwent single use flexible ureteroscopy (FURS).
| Study group | Role | What they receive |
|---|---|---|
| Mini PCNL | Experimental | Patients underwent mini percutaneous nephrolithotomy (PCNL) technique. Receives: Procedure: Mini percutaneous nephrolithotomy |
| FURS | Experimental | Patients underwent single use flexible ureteroscopy (FURS). Receives: Procedure: Flexible ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Incidence of complications will be recorded according to the Clavien-Dindo grading system.
The Grades of the Clavien-Dindo Classification:
- Grade I: Any deviation from the normal postoperative course. It does not need pharmacological treatment or surgical, endoscopic, and radiological interventions.
- Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I. Blood transfusions and total parenteral nutrition.
- Grade III: Requires surgical, endoscopic, or radiological intervention. Grade IIIa: Intervention done without general anesthesia. Grade IIIb: Intervention done under general anesthesia.
- Grade IV: Life-threatening complication requiring intermediate or intensive care unit management. Grade IVa: Single-organ dysfunction. Grade IVb: Multi-organ failure.
- Grade V: Death of the patient.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Operative time
Operative time will be recorded from start till the end of surgery.
Measured: Up to 3 hours
Fluoroscopy time
Total duration of fluoroscopy exposure during the procedure will be measured in seconds, from the first fluoroscopic image until the final image
Measured: Intraoperatively
Postoperative stenting
Percentage of participants requiring ureteral stent placement after the procedure will be recorded.
Measured: Immediately after the procedure (Up to 2 hours)
Lenght of hospital stay
Lenght of hospital stay will be recorded from the admission till the discharge from the hospital.
Measured: Till the discharge from hospital (Up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jul 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mini Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Elmaadawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836192
- Sponsor's protocol ID
- 34812/7/21
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)
- ClinicalTrials.gov ID
- NCT07836192
- Acronym / sponsor ID
- 34812/7/21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 23 Sep 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 work aimed to compare the safety and efficacy of retrograde intrarenal surgery using single-use flexible ureteroscopy (FURS) with mini-percutaneous nephrolithotomy (PCNL) in children with renal stones measuring 10-30 mm.
Detailed description
Children have a smaller pelvicalyceal system, more delicate tissues, and a more curved ureter compared to adults.
While percutaneous nephrolithotomy (PCNL) offers excellent stone-free rates for large stones (>2 cm), its application in children presents challenges due to their smaller renal anatomy and increased kidney mobility.
Retrograde intrarenal surgery with flexible ureteroscopy (FURS) major advantage lies in utilizing natural orifices, eliminating the need for additional access routes with theoretically enhanced faster postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini PCNL | Experimental | Procedure: Mini percutaneous nephrolithotomyPatients underwent mini percutaneous nephrolithotomy (PCNL) technique. |
| FURS | Experimental | Procedure: Flexible ureteroscopyPatients underwent single use flexible ureteroscopy (FURS). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children <18 years old.
- Both sexes.
- Single calyceal renal stone of 10-20 mm in maximum diameter, single renal pelvic stone of 10-20 in maximum diameter with history of failed, extracorporeal shock wave lithotripsy (ESWL) or refused ESWL, single renal stone 20-30 mm in maximum diameter and multiple renal stones with total stone size 10-30 mm (sum of maximum dimensions of each stone).
Key exclusion criteria (3 listed)
- Patients with uncorrected coagulopathy.
- Renal or ureteral malformation.
- Cases with significant anatomical obstruction requiring separate intervention or associated metabolic disorder.
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 |
|---|---|---|
| Mini percutaneous nephrolithotomyPatients underwent mini percutaneous nephrolithotomy (PCNL) technique. | Procedure or surgery | Mini PCNL |
| Flexible ureteroscopyPatients underwent single use flexible ureteroscopy (FURS). | Procedure or surgery | FURS |
Primary outcome
Incidence of complications
Time frame: 24 hours postoperatively
Incidence of complications will be recorded according to the Clavien-Dindo grading system. The Grades of the Clavien-Dindo Classification: * Grade I: Any deviation from the normal postoperative course. It does not need pharmacological treatment or surgical, endoscopic, and radiological interventions. * Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I. Blood transfusions and total parenteral nutrition. * Grade III: Requires surgical, endoscopic, or radiological intervention. Grade IIIa: Intervention done without general anesthesia. Grade IIIb: Intervention done under general anesthesia. * Grade IV: Life-threatening complication requiring intermediate or intensive care unit management. Grade IVa: Single-organ dysfunction. Grade IVb: Multi-organ failure. * Grade V: Death of the patient.
4 secondary outcomes
Operative time
Time frame: Up to 3 hours
Fluoroscopy time
Time frame: Intraoperatively
Postoperative stenting
Time frame: Immediately after the procedure (Up to 2 hours)
Lenght of hospital stay
Time frame: Till the discharge from hospital (Up to 2 weeks)
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 23 Sep 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Mini percutaneous nephrolithotomy and Flexible ureteroscopy in people with Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery, run by Tanta 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 23 Sep 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?
Incidence of complications (time frame: 24 hours 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 23 Sep 2026.