Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

Child, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413603
• Other study ID #: Mahmoud Moubarak
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: July 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 30, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Child, Only
• Kidney Calculi
• Nephrolithiasis
• Stone, Kidney

Intervention

Procedure:
• ultrasonic focus Shock wave lithotripsy
successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone
• fluoroscopic focus Shock wave lithotripsy
successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

Locations

Country	Name	City	State
Egypt	Urology department - faculty of medicine, South Valley university	Qina

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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