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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Single Renal stones measured 6- 20 mm in maximal dimension.

ESWL will be planned as the first line of treatment.

Disqualifiers

Patients with internal ureteral stent.

ureteral stones.

abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).

active UTI at time of ESWL.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

108 Participants
are grouped into 1 trial group
Group A: Pediatric Patients Undergoing ESWL

Trial outcomes

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.

Time frame
3 months with maximum 3 sessions ESWL

Secondary outcomes

1

Secondary Outcomes Related to SWE and ESWL

Assessment of secondary outcomes including: 1. correlation between shear wave elastography (SWE) values and CT-derived Hounsfield units (HU). 2. Correlation between SWE and stone composition.

Time frame
Up to 3 months after ESWL

Other outcomes

Sponsors and contacts

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