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.
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
- Conditions the study is for
- Stone Heterogeneity Index, Shock Wave Lithotripsy
- 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.
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
- Conditions
- Stone Heterogeneity Index, Shock Wave Lithotripsy
- 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.
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)
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.
- First posted18 Jun 2026
- Study start4 Mar 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone Heterogeneity IndexStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Anas, Mansoura University
- Investigators
- Marwan A Ismail, MSc, Principal investigator, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Stone Heterogeneity Index in Predicting Shock Wave Lithotripsy Outcomes for Urinary Calculi in Pediatrics
- ClinicalTrials.gov ID
- NCT07657832
- Acronym / sponsor ID
- SHI/SWL / MD.25.01.941
- Conditions
- Stone Heterogeneity Index, Shock Wave Lithotripsy
- Keywords
- stone heterogeneity index, shock wave lithotripsy, Pediatric Calculi
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan A Ismail, MSc principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
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.