A Prospective Observational Comparison of SMP and ESWL for the Treatment of Renal Stones ≥20 mm in Children (IAU-04)

Study Overview
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Brief Summary
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ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.

Detailed Description
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To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.

Official Title
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A Prospective Observational Comparison of Super-mini Percutaneous Nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the Treatment of Renal Stones ≥20 mm in Children: An IAU Study

Conditions
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Kidney Stone

Intervention / Treatment
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* Procedure: Super-mini percutaneous nephrolithotomy (SMP)
* Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ≤14 years old with renal Stones ≥20 mm Willing and able to sign informed consent Normal renal function No stone-related surgical history American Society of Anesthesiology (ASA) score 1-2 Exclusion Criteria: Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction) Uncorrected UTI Abnormal coagulation function Morbid obese children (BMI≥35）

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Super-Mini Percutaneous Nephrolithotomy<br>Patients undergo SMP | Procedure: Super-mini percutaneous nephrolithotomy (SMP)<br>* SMP will be performed under general anesthesia in prone/supine position. Renal puncture will be performed under ultrasound/fluoroscopy guidance based on the preference of the participating surgeon. Tracts will be dilated to 14 Fr. Stone fragmentation will be performed with holmium laser and fragments will be extracted with the active suction system. For the exit strategy, placement of a nephrostomy tube or JJ stent will be decided by the participating surgeon.<br>|
| Extracorporeal Shock Wave Lithotripsy<br>Patients undergo ESWL | Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)<br>* ESWL will be performed under sedation/analgesia, shock wave lithotripsy parameters will be determined based on the device and the settings of local center. For patients requiring multiple sessions, maximum 3 (or more) sessions will be allowed. Ureteral stenting prior to ESWL will be performed based on the decision of the participating center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Stone clearance on the computed tomography (2mm thickness) | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | Number of participants requiring blood transfusion after the procedure | Postoperative day 1 | 
| auxiliary procedures | Number of patients requiring additional auxiliary procedures such as second look PCNL, SWL, Ureteroscopy | Postoperative month 3 | 
| hospital stay | From date of admission until the date of discharge,length of hospital stay | Postoperative month 3 | 
| complications | Rate of postoperative complications using the Clavien-Dindo system | Postoperative month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous nephrolithotomy, pcnl, miniperc, smp, children