Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

Not Applicable

Completed

• Conditions: Stone, Kidney; Child, Only
• Interventions: Procedure: ultrasonic focus Shock wave lithotripsy; Procedure: fluoroscopic focus Shock wave lithotripsy

• Registration Number: NCT05413603
• Lead Sponsor: Egymedicalpedia

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-05-19
• Study Start: 2022-05-25
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-10
• Primary Completion: 2023-05-25
• Study Completion: 2023-05-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

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Exclusion Criteria

1. Previous percutaneous nephrolithotripsy at the same side.
2. Previous renal exploration for stones at the same side.
3. Positive urinary culture.
4. Calyceal stones

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluoroscopic focus Shock wave lithotripsy	fluoroscopic focus Shock wave lithotripsy	Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone
ultrasonic focus Shock wave lithotripsy	fluoroscopic focus Shock wave lithotripsy	Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone
ultrasonic focus Shock wave lithotripsy	ultrasonic focus Shock wave lithotripsy	Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone
fluoroscopic focus Shock wave lithotripsy	ultrasonic focus Shock wave lithotripsy	Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone

Primary Outcome Measures

Name	Time	Method
Lithotripsy or nephrolithotripsy by Shock waves	from baseline to 3 months after the Lithotripsy date.	Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.

Secondary Outcome Measures

Name	Time	Method
Complications of shockwave lithotripsy	through study completion, an average of 1 year	to evaluate postoperative complications of the lithotripsy as : 1. Incidence of Hematuria; 2. Incidence of Fever; 3. Incidence of UTI; 4. Serum creatinine level in blood; 5. Rate of hydronephrosis

Trial Locations

Locations (1)

Urology department - faculty of medicine, South Valley university; 🇪🇬 Qinā, Egypt