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Stone Heterogeneity Index and Shock Wave Lithotripsy Outcomes in Pediatrics

Role of Stone Heterogeneity Index in Predicting Shock Wave Lithotripsy Outcomes for Urinary Calculi in Pediatrics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07657832
Acronym
SHI/SWL
Enrollment
286
Registered
2026-06-18
Start date
2025-03-04
Completion date
2026-08-01
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock Wave Lithotripsy, Stone Heterogeneity Index

Keywords

stone heterogeneity index, shock wave lithotripsy, Pediatric Calculi

Brief summary

To assess the role of SHI in SWL outcomes for upper urinary tract calculi in pediatric population.

Detailed description

Urolithiasis is a common health problem among children with an estimated incidence of approximately 5 to 36 per 100,000 children. The risk of recurrence of urolithiasis in children is high (up to 50% within 3 years of the first episode) and many have a predisposing metabolic risk factor, such as hypercalciuria (1). The recurrence of kidney stones in adults is very common, with up to 50% of adult incident stone formers experiencing a second occurrence within 5-10 years (2). However, the reported rates of recurrence among pediatric series are more variable, ranging from 16 to 67% at a median interval of 1-5 years between episodes (3-5). Shock wave lithotripsy (SWL) is one of the first-line treatments in children for kidney stones smaller than 2 cm (6). There is wide disparity in the stone free rates documented in the literature for SWL in children ranging from 33 to 95%. The results are incomparable not just for lack of information but also because of variability of the confounding factors like patient-related factors including age, gender, patient tolerability, symptom severity, anatomy, and skin to stone distance and stone related factors including stone burden, location, composition, beside the type of lithotripter used, and the number of shockwaves in each session. All these factors impact SWL outcome in children. One such stone factor is stone density, diagnosed using non-contrast computer tomography (NCCT) scans (7, 8). There are some factors that affect the success of SWL and stone composition is one of them. Hounsfield unit is known to be an independent predictor of ESWL success in adults (9). El-Assmy et al. showed that ≤ 600 HU is an independent predictor for ESWL success in children (10), McAdams et al. divided the patients into two groups (\< 1000 and ≥ 1000 HU) and concluded that \< 1000 HU is an important predictor of ESWL success (11). Numerous studies have suggested an inverse association between stone density and SWL success with cut-offs are ranging from as low as 482 HU up to 1000 HU. However, these studies have shown variation in the assessment, HU markers, and utility of HU measurements. Researchers have also looked into adjunct factors to help maximize predictability of success (8) . The majority specified the method of measuring mean stone density (MSD), creating single elliptical region of interest (ROI), a squared 10 × 10-pixel map, or a freehand ROI drawn along the stone edge to take into account abnormal shapes. These studies used 3 ROI within the image, either over-lapping or non-overlapping, and taking the mean of the three results or the peak HU (12-14), some measured the stones on a single axial plane that displayed the stone at its maximal diameter (15). A single study defined MSD as the average of the minimum and maximum HU readings (14). Stone heterogeneity index (SHI) was identified to be a better indicator of success in patients with larger stones. SHI designated as the standard deviation of HU was found to be a truer reflection of SWL success in patients with larger stones, with higher heterogeneity likely to result in clearance. This new ratio was seen to have a higher negative predictive value than stone attenuation alone in predicting stone composition

Interventions

None listed

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age between 1year and 18 years. * Both ureteric stone with size 5 mm-10 mm and renal stone with size 10 mm-20 mm. * Only those patients who had NCCT available for review after at least 3 months from the last session of SWL will be included in the study.

Exclusion criteria

* Patients \>18 years of age. * Subjects suffering from active urinary tract infection. * Multiple renal calculi. * Presence of anatomical renal abnormalities that may affect stone clearance and renal insufficiency.

Design outcomes

Primary

MeasureTime frame
To assess the role of stone heterogeneity index (SHI) as an indicator of success of shock wave lithotripsy (SWL) in pediatric patients with upper urinary tract stones after three months2 years

Secondary

MeasureTime frame
Assessment of independent factors affecting re-growth of residual fragments (RFs), spontaneous passage, and re-operation rates for clinically insignificant RFs after one year of follow up2 years

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMarwan A Ismail, MSc

Mansoura University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026