Normal Pediatric Liver and Spleen SWE

NCT06930066 | Completed

• 1 other identifier: 2024/522
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to determine normal liver and spleen stiffness values in healthy children using shear wave elastography (SWE). The study will include participants from the pediatric age group without known liver or spleen disease. SWE measurements will be performed non-invasively to establish reference values. The results may contribute to improving diagnostic accuracy in pediatric elastography applications.

Conditions

Liver Stiffness; Spleen Stiffness; Shear Wave Elastography in Healthy Children; Normal Organ Elasticity; Pediatric Elastography

Keywords

Shear Wave Elastography; Liver Stiffness; Spleen Stiffness; Pediatric Elastography; Normal Reference Values; Organ Stiffness Measurement

Outcome Measures

Primary Outcomes (1)

• Normal liver and spleen stiffness values

  This study aims to establish reference values for liver and spleen stiffness in healthy children using shear wave elastography (SWE).

  Day 1

Study Arms (1)

Healthy Children

This group includes healthy pediatric participants with no known liver or spleen disease. Each participant will undergo non-invasive shear wave elastography (SWE) to assess liver and spleen stiffness for the purpose of establishing normal reference values.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of healthy children aged 0-18 years, with no known liver or spleen pathology. These participants will be selected from pediatric clinics, specifically those who are seeking routine healthy child check-ups and have no underlying diseases. Non-invasive shear wave elastography (SWE) will be used to assess normal liver and spleen stiffness values. Participants will be selected based on inclusion criteria of being free from any liver or spleen disease, and exclusion criteria will ensure that children with known hepatic or splenic conditions are not included. Parental or guardian consent will be obtained for each participant.

You may qualify if:

• Healthy children aged 0-18 years
• No known liver or spleen pathology
• Written informed consent obtained from parents or guardians

You may not qualify if:

• Known liver disease (e.g., hepatitis, cirrhosis)
• Known spleen disease (e.g., splenomegaly)
• Any history of liver or spleen disease
• Age outside the 0-18 years range

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selçuk University Faculty of Medicine

Konya, Konya, 42130, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: July 30, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

TU (1)