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

NCT07506031 | Recruiting

• 1 other identifier: FMBSUREC/02122025/Badawy
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Urolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Outcomes Related to SWE and ESWL

  Up to 3 months after ESWL

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

faculty of medicine Beni Suef university hospital

Banī Suwayf, 62511, Egypt

RECRUITING

Central Study Contacts

Mahmoud Abdallah Mahmoud, MD of urology

CONTACT

+2001155361979; mahmoud.abdalla@med.bsu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology faculty of medicine Beni Suef university

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 1, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)