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Shear Wave Elastography for Predicting Extracorporeal Shock Wave Lithotripsy Outcomes in Pediatric Renal Stones

Study acronym: SWE-ESWL
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Trial completed Show 6 more changesShow less
    • Enrollment target: estimated 108 to confirmed 110
    • Primary completion date changed from estimate of May 2026 to May 1, 2026
    • Study completion date changed from estimate of Jun 2026 to Jun 1, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound. Pediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition. This study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.
Trial Details
NCT Number NCT07506031
Lead Sponsor Beni-Suef University
Conditions
(from sponsor)		 Pediatric Urolithiasis
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov