Shear Wave Elastography for Predicting Extracorporeal Shock Wave Lithotripsy Outcomes in Pediatric Renal Stones (SWE-ESWL)

Evaluating Shear Wave Elastography as a Predictor of Extracorporeal Shock Wave Lithotripsy Outcomes and Stone Composition in Children "A Prospective Study"

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Urolithiasis

• Study Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

• Study Contact: Name: Mahmoud Abdallah Mahmoud, MD of urology; Phone Number: +2001155361979; Email: mahmoud.abdalla@med.bsu.edu.eg

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Recruiting
    • faculty of medicine Beni Suef university hospital
    • Contact: doaa mahmoud kalil, MD; Phone Number: 01152091011; Email: drm_abdallah_88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients under 18 years of age diagnosed with renal stones measuring 6-20 mm and scheduled for extracorporeal shock wave lithotripsy (ESWL). Patients will be recruited from the outpatient clinic and followed for 3 months.

Proper history, examination and basic laboratory investigations (CBC, coagulation profile, kidney and Liver functions, urine analysis and urine culture and sensitivity) will be performed for all participants.

Low dose CTUT will be performed as usual for all patient to record stone location, size (maximum longitudinal and transverse dimensions), and HU.

Renal stone elastography values will be measured by a single radiologist using grayscale renal US and SWE.

SWE measurements will be performed once prior to ESWL. A Philips EPİQ7 system (Philips Medical Systems, Bothell, WA) with a 1-5-MHz abdominal probe will be used for the procedure.

Description

Inclusion Criteria:

• Inclusion criteria:

  1. Single Renal stones measured 6- 20 mm in maximal dimension.
  2. ESWL will be planned as the first line of treatment.

Exclusion Criteria:

1. Patients with internal ureteral stent.
2. ureteral stones.
3. abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).
4. active UTI at time of ESWL.
5. coagulopathy .

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Pediatric Patients Undergoing ESWL; Pediatric patients (<18 years) with renal stones (6-20 mm) undergoing extracorporeal shock wave lithotripsy (ESWL). All patients will undergo baseline shear wave elastography (SWE) assessment prior to treatment. Patients will be followed for 3 months to evaluate ESWL success and its correlation with SWE measurements, Hounsfield units (HU), and stone composition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESWL Success Rate	Treatment success defined as absence of stone fragments or presence of clinically insignificant residual fragments ≤2 mm on imaging, without symptoms, obstruction, or urinary tract infection.	3 months with maximum 3 sessions ESWL

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcomes Related to SWE and ESWL	Assessment of secondary outcomes including: correlation between shear wave elastography (SWE) values and CT-derived Hounsfield units (HU).; Correlation between SWE and stone composition.	Up to 3 months after ESWL

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FMBSUREC/02122025/Badawy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No