Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

Study Overview
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Brief Summary
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Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Detailed Description
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Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease. Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone

Official Title
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Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.

Conditions
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Stone, Kidney, Child, Only

Intervention / Treatment
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* Procedure: ultrasonic focus Shock wave lithotripsy
* Procedure: fluoroscopic focus Shock wave lithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm Exclusion Criteria: Previous percutaneous nephrolithotripsy at the same side. Previous renal exploration for stones at the same side. Positive urinary culture. Calyceal stones

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluoroscopic focus Shock wave lithotripsy<br>Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone | Procedure: ultrasonic focus Shock wave lithotripsy<br>* successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone<br>Procedure: fluoroscopic focus Shock wave lithotripsy<br>* successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone<br>|
| Active Comparator: ultrasonic focus Shock wave lithotripsy<br>Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone | Procedure: ultrasonic focus Shock wave lithotripsy<br>* successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone<br>Procedure: fluoroscopic focus Shock wave lithotripsy<br>* successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lithotripsy or nephrolithotripsy by Shock waves | Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones. | from baseline to 3 months after the Lithotripsy date. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of shockwave lithotripsy | to evaluate postoperative complications of the lithotripsy as : Incidence of Hematuria Incidence of Fever Incidence of UTI Serum creatinine level in blood Rate of hydronephrosis | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric renal stones, ultrasound shock waves, fluoroscope.