Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

Egymedicalpedia

Status: Completed

Conditions: Stone, Kidney; Child, Only

Treatments: Procedure: fluoroscopic focus Shock wave lithotripsy; Procedure: ultrasonic focus Shock wave lithotripsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05413603

Mahmoud Moubarak

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

fluoroscopic focus Shock wave lithotripsy

Active Comparator group

Description:

Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone

Treatment:

Procedure: ultrasonic focus Shock wave lithotripsy

Procedure: fluoroscopic focus Shock wave lithotripsy

ultrasonic focus Shock wave lithotripsy

Active Comparator group

Description:

Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone

Treatment:

Procedure: ultrasonic focus Shock wave lithotripsy

Procedure: fluoroscopic focus Shock wave lithotripsy