Stone Heterogeneity Index and Shock Wave Lithotripsy Outcomes in Pediatrics

NCT07657832 | Active Not Recruiting DMC

• 1 other identifier: MD.25.01.941
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stone Heterogeneity Index; Shock Wave Lithotripsy

Keywords

stone heterogeneity index; shock wave lithotripsy; Pediatric Calculi

Outcome Measures

Primary Outcomes (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

  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

  2 years

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Mansoura, Egypt

Location

Study Officials

• Marwan A Ismail, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: March 4, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)