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Completed

NCT Number: NCT05413603

Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

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

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Key information

Conditions

Stone, Kidney Calculi Child, Only Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology department - faculty of medicine, South Valley university

Qina, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasonic focus Shock wave lithotripsy

Procedure

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

Procedure

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

Primary outcomes

  1. Lithotripsy or nephrolithotripsy by Shock waves

    Time frame: 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 outcomes

  1. Complications of shockwave lithotripsy

    Time frame: through study completion, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2022
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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