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Stone Heterogeneity IndexSHI/SWLNCT07657832

Stone Heterogeneity Index and Shock Wave Lithotripsy Outcomes in Pediatrics

An observational study of Stone Heterogeneity Index and Shock Wave Lithotripsy, run by Mansoura University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To assess the role of SHI in SWL outcomes for upper urinary tract calculi in pediatric population. Read more about this study

Who is it for?
Ages 1 year to 18 years
How many people
286 participants
Where
1 siteEgypt
Study dates
4 Mar 2025to 1 Aug 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The medical records of pediatric patients who underwent SWL at the Urologyy and Nephrology Center from January 2016 toDecember 2024 willl be retrospectively reviewed. Gender, age, history of SWL or stone surgery, and comorbidities will be recorded as patients' characteristics. Stone features on NCCT include the size, location, skin to stone distance (SSD), MSD, and SHI. Hounsfield unit (HU): Multiple regions of interest (ROI), incorporating the stone but not the surrounding soft tissue. This will be done creating single elliptical ROI, a squared 10 × 10-pixel map, or a freehand ROI drawn along the stone edge to take into account abnormal shapes. We will used 3 ROI within the image, either over-lapping or non-overlapping, and taking the mean of the three results or the peak HU. Stone heterogeneity index (SHI): SHI will be designated as the standard deviation of Hounsfield's units in the same specified region of interest.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura University

    Al Mansurah, Mansoura

Other trials in Egypt

About this study

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

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

Read the 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

Keywords
stone heterogeneity index, shock wave lithotripsy, Pediatric Calculi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 months

    Measured: 2 years

Secondary outcomes (1)
  1. 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 up

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start4 Mar 2025
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
286 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07657832
Sponsor's protocol ID
MD.25.01.941
Acronym
SHI/SWL
Status last verified
Jan 2026
First submitted
13 Jun 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stone Heterogeneity Index and Shock Wave Lithotripsy, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 months (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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