UrolithiasisNCT06571617
F-URS and Mini PCNL for Pediatric Urolithiasis
A study testing Mini PCNL (mini percutaneous nephrolithotomy) and RIRS (retrograde intrarenal surgery/ flexible URS) in people with Urolithiasis, run by Mansoura University at 1 site in Egypt.
Trial summary
To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones (10-20 mm) through a RCT. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Mini PCNL (mini percutaneous nephrolithotomy) and RIRS (retrograde intrarenal surgery/ flexible URS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 5 Apr 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 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 12 years or younger
- American society of anesthesia (ASA) score I or II.
- Renal stone measured between 10-20 mm.
- An informed consent obtained from their parents
Who cannot join
- Bleeding tendency
- Active urinary tract infection (UTI).
- Renal anatomical abnormalities (ectopic kidney, horseshoe kidney, ADPCK).
- Skeletal deformities
- Concomitant ureteric stone or stricture.
Trial locations and contacts
1 site in 1 country.
Ahmed Shoma contact
Egypt1 site
Urology and nephrology center
Al Mansurah, Dakahlia Governorate, 35516
Ramy Elbaz, MD, 00201092759184, ramifrag7@gmail.com
Ahmed Shoma, PhD, +201223766818
About this study
Official title: Retrograde Intrarenal Surgery Versus Mini-Percutaneous Nephrolithotomy for Treatment of Medium Size Pediatric Renal Stones (10-20millimeters). A Randomized Controlled Trial
To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones (10-20 mm) through a RCT.
Read the detailed description
Pediatric urolithiasis has become a major health problem, especially in the developing countries. It is a well-known risk factor for renal impairment and end-stage kidney disease (ESKD). Also, it's associated with a bad quality of life (Qol) for both parents and child. Children represent 2-3% of the total population of stone-formers. Similar to adult urolithiasis, the prevalence of pediatric stones is widely variable in different parts of the world. it changes with sex, race, geographical and climatic factors.
Renal stones in pediatric patients are usually caused by an underlying disorder, such as anatomical and metabolic anomalies or recurrent urinary tract infections, So, children with renal stones are at higher risk for recurrence and multiple interventions on the kidney Over the last decades, the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided. According to the last guidelines from the European Association of Urology (EAU) and the American urological association (AUA), the standard treatment of renal stones between1-2 cm is shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL) and retrograde intrarenal surgery (RIRS). However, the first choice between these modalities is still controversial until now.
SWL is one of the most effective treatment options for pediatric stones, however, its long-term effect on developing kidneys is not clear yet. Also, its efficacy decreases significantly with increasing stone size and multiplicity. The requirement for multiple sessions and the need for general anesthesia in children are other drawbacks of this procedure.
PNL has significantly higher stone-free rates (SFR) and lower requirements for auxiliary procedures compared with SWL. This trend is further promoted by the introduction of miniaturized PNL (mini-perc), which is postulated to be less invasive compared with standard PNL because of the miniaturized instruments. However, PNL may present problems in children, despite modifications, such as the "mini-perc," because of the small size and mobility of the pediatric kidney, friable renal parenchyma, and the small size of the collecting system.
On the other hand, the quality of flexible ureteroscopy and endoscopic instruments showed an outstanding development over the last years which made RIRS a feasible option for pediatric renal stones. Experience suggests that flexible ureteroscopy has a lower risk of kidney damage and bleeding. However, the disadvantage of RIRS in children includes the need toindwell double-J stent in advance, the risk of ureteral injury, and the high cost of equipment purchase and maintenance, which may limit the application of RIRS in children with upper urinary tract calculi.
Until now, there is a few number of randomized trials compared mini-perc PNL versus RIRS for pediatric renal stones. SO, there is no clear evidence for the superiority of one option over the other regarding stone- free rate, complication rate, auxiliary procedures, and second sessions.
Recently, a new Trifecta tool which includes stone-free status in a single session without complications was set in motion to help standard reporting of the outcome of stone intervention in line with assessing its efficacy and safety.
In the present study, we will try to overcome the limitations of the previous studies by designing a prospective randomized controlled trial (RCT). To the best of our knowledge, the present study is the first RCT comparing mini-perc PNL versus RIRS for the management medium -size renal stones (10-20mm) in children.
- Conditions
- Urolithiasis
- Being tested
- Mini PCNL (mini percutaneous nephrolithotomy), RIRS (retrograde intrarenal surgery/ flexible URS)
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini PCNL (mini percutaneous nephrolithotomy)Procedure or surgery
half of the cases will be treated using mini PCNL
RIRS (retrograde intrarenal surgery/ flexible URS)Procedure or surgery
THE OTHER HALF WILL BE TRAETED USING Flexible URS
| Study group | Role | What they receive |
|---|---|---|
| Mini PCNL (mini percutaneous nephrolithotomy) | Active comparator | Under general anesthesia, a 5/ 6 Fr ureteric catheter will be placed in the pelvicalyceal system. then the patient is turned to the prone position. A puncture will be done using an 18 G needle under fluoroscopy guidance. The tract will be dilated up to 15 F and then a sheath will be placed. A 12 F nephoscope (MIP-M, Karl Storz Endoscopy, Tuttlingen, Germany) will be used. Stone fragmentation will be performed using holmium YAG Laser energy. Then, Fragments will be evacuated using vacuum cleaner effect, tipless basket, or 5 FR stone forceps for stone analysis. A nephrostomy tube 12 Fr will be fixed at the end of the procedure. Receives: Procedure: Mini PCNL (mini percutaneous nephrolithotomy) |
| RIRS (retrograde intrarenal surgery/ flexible URS) | Active comparator | Under general anesthesia, the children will be placed in the lithotomy position . Cystoscopy or rigid ureteroscopy will be performed to place a hydrophilic guidewire to the renal pelvis under fluoroscopic guidance. After passing a 0.035/0.038-inch safety guidewire into the renal pelvis, a ureteral access sheath will be placed (9.5/11.5 Fr, 35 cm) will be used according to the surgeon preference. . RIRS will be performed using a single use digital Flexible ureteroscopy . A manual irrigation pump system will be used to hydro dilate the ureter during ureteroscopy. The stones will be fragmented with a holmium:YAG laser until they will be deemed small enough to pass spontaneously. Some residual fragments will be removed by tipless nitinol basket for stone analysis. A double-J stent OR URETERIC CATHETER will be placed at the end of the procedure based on surgeon's decision. . Receives: Procedure: RIRS (retrograde intrarenal surgery/ flexible URS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary outcome, the stone-free rate
no evidence of any residual fragment by NCCT or KUB or clinical insignificant residual fragments (CIRF) ≤ 4 mm in maximum diameter in a single session within the first month postoperatively.
Measured: at 4 weeks postoperatively
Secondary outcomes (1)
The Secondary outcomes, perioperative parameters
intraoperative complications, operation time in minutes, fluoroscopy time in seconds, lasing time in seconds, laser energy in joles, hemoglobin deficit, postoperative complications, hospital stay in days
Measured: intraoperative and first day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start10 Sep 2024 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion5 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Patients will be randomized using computer-generated random tables in a 1:1 ratio to be allocated to one of two groups, the first group will undergo mini-PNL, and the second group will undergo RIRS.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Elbaz, Mansoura University
- Investigators
- Ramy F Elbaz, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571617
- Sponsor's protocol ID
- 22.08.684
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: plan to share the surgical techniques in both arms, post operative outcomes and statistics results
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Intrarenal Surgery Versus Mini-Percutaneous Nephrolithotomy for Treatment of Medium Size Pediatric Renal Stones (10-20millimeters). A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06571617
- Acronym / sponsor ID
- 22.08.684
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones (10-20 mm) through a RCT.
Detailed description
Pediatric urolithiasis has become a major health problem, especially in the developing countries. It is a well-known risk factor for renal impairment and end-stage kidney disease (ESKD). Also, it's associated with a bad quality of life (Qol) for both parents and child. Children represent 2-3% of the total population of stone-formers. Similar to adult urolithiasis, the prevalence of pediatric stones is widely variable in different parts of the world. it changes with sex, race, geographical and climatic factors.
Renal stones in pediatric patients are usually caused by an underlying disorder, such as anatomical and metabolic anomalies or recurrent urinary tract infections, So, children with renal stones are at higher risk for recurrence and multiple interventions on the kidney Over the last decades, the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided. According to the last guidelines from the European Association of Urology (EAU) and the American urological association (AUA), the standard treatment of renal stones between1-2 cm is shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL) and retrograde intrarenal surgery (RIRS). However, the first choice between these modalities is still controversial until now.
SWL is one of the most effective treatment options for pediatric stones, however, its long-term effect on developing kidneys is not clear yet. Also, its efficacy decreases significantly with increasing stone size and multiplicity. The requirement for multiple sessions and the need for general anesthesia in children are other drawbacks of this procedure.
PNL has significantly higher stone-free rates (SFR) and lower requirements for auxiliary procedures compared with SWL. This trend is further promoted by the introduction of miniaturized PNL (mini-perc), which is postulated to be less invasive compared with standard PNL because of the miniaturized instruments. However, PNL may present problems in children, despite modifications, such as the "mini-perc," because of the small size and mobility of the pediatric kidney, friable renal parenchyma, and the small size of the collecting system.
On the other hand, the quality of flexible ureteroscopy and endoscopic instruments showed an outstanding development over the last years which made RIRS a feasible option for pediatric renal stones. Experience suggests that flexible ureteroscopy has a lower risk of kidney damage and bleeding. However, the disadvantage of RIRS in children includes the need toindwell double-J stent in advance, the risk of ureteral injury, and the high cost of equipment purchase and maintenance, which may limit the application of RIRS in children with upper urinary tract calculi.
Until now, there is a few number of randomized trials compared mini-perc PNL versus RIRS for pediatric renal stones. SO, there is no clear evidence for the superiority of one option over the other regarding stone- free rate, complication rate, auxiliary procedures, and second sessions.
Recently, a new Trifecta tool which includes stone-free status in a single session without complications was set in motion to help standard reporting of the outcome of stone intervention in line with assessing its efficacy and safety.
In the present study, we will try to overcome the limitations of the previous studies by designing a prospective randomized controlled trial (RCT). To the best of our knowledge, the present study is the first RCT comparing mini-perc PNL versus RIRS for the management medium -size renal stones (10-20mm) in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized using computer-generated random tables in a 1:1 ratio to be allocated to one of two groups, the first group will undergo mini-PNL, and the second group will undergo RIRS.
| Arm | Type | Receives |
|---|---|---|
| Mini PCNL (mini percutaneous nephrolithotomy) | Active comparator | Procedure: Mini PCNL (mini percutaneous nephrolithotomy)Under general anesthesia, a 5/ 6 Fr ureteric catheter will be placed in the pelvicalyceal system. then the patient is turned to the prone position. A puncture will be done using an 18 G needle under fluoroscopy guidance. The tract will be dilated up to 15 F and then a sheath will be placed. A 12 F nephoscope (MIP-M, Karl Storz Endoscopy, Tuttlingen, Germany) will be used. Stone fragmentation will be performed using holmium YAG Laser energy. Then, Fragments will be evacuated using vacuum cleaner effect, tipless basket, or 5 FR stone forceps for stone analysis. A nephrostomy tube 12 Fr will be fixed at the end of the procedure. |
| RIRS (retrograde intrarenal surgery/ flexible URS) | Active comparator | Procedure: RIRS (retrograde intrarenal surgery/ flexible URS)Under general anesthesia, the children will be placed in the lithotomy position . Cystoscopy or rigid ureteroscopy will be performed to place a hydrophilic guidewire to the renal pelvis under fluoroscopic guidance. After passing a 0.035/0.038-inch safety guidewire into the renal pelvis, a ureteral access sheath will be placed (9.5/11.5 Fr, 35 cm) will be used according to the surgeon preference. . RIRS will be performed using a single use digital Flexible ureteroscopy . A manual irrigation pump system will be used to hydro dilate the ureter during ureteroscopy. The stones will be fragmented with a holmium:YAG laser until they will be deemed small enough to pass spontaneously. Some residual fragments will be removed by tipless nitinol basket for stone analysis. A double-J stent OR URETERIC CATHETER will be placed at the end of the procedure based on surgeon's decision. . |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 12 years or younger
- American society of anesthesia (ASA) score I or II.
- Renal stone measured between 10-20 mm.
- An informed consent obtained from their parents
Key exclusion criteria (5 listed)
- Bleeding tendency
- Active urinary tract infection (UTI).
- Renal anatomical abnormalities (ectopic kidney, horseshoe kidney, ADPCK).
- Skeletal deformities
- Concomitant ureteric stone or stricture.
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 PCNL (mini percutaneous nephrolithotomy)half of the cases will be treated using mini PCNL | Procedure or surgery | Mini PCNL (mini percutaneous nephrolithotomy) |
| RIRS (retrograde intrarenal surgery/ flexible URS)THE OTHER HALF WILL BE TRAETED USING Flexible URS | Procedure or surgery | RIRS (retrograde intrarenal surgery/ flexible URS) |
Primary outcome
the primary outcome, the stone-free rate
Time frame: at 4 weeks postoperatively
no evidence of any residual fragment by NCCT or KUB or clinical insignificant residual fragments (CIRF) ≤ 4 mm in maximum diameter in a single session within the first month postoperatively.
1 secondary outcome
The Secondary outcomes, perioperative parameters
Time frame: intraoperative and first day postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Yes. plan to share the surgical techniques in both arms, post operative outcomes and statistics results
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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.
Ahmed Shoma contact
Ramy F Elbaz principal investigator
Mansoura University
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 PCNL (mini percutaneous nephrolithotomy) and RIRS (retrograde intrarenal surgery/ flexible URS) in people with Urolithiasis, run by Mansoura 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramy F Elbaz (01092759184, ramifrag7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the primary outcome, the stone-free rate (time frame: at 4 weeks 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 26 Aug 2024.