Normal Pediatric Liver and Spleen SWE

Selcuk University

Status: Begins enrollment this month

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

Study type: Observational

Funder types: Other

Identifiers

NCT06930066

2024/522

Details and patient eligibility

About

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.

Full description

Shear wave elastography (SWE) is a non-invasive imaging method used to assess tissue stiffness. While reference values for SWE have been established in adults, data regarding normal liver and spleen stiffness in children are limited. This single-center, cross-sectional observational study aims to establish normative SWE values for the liver and spleen in the pediatric age group. Children with no known liver or spleen pathology will undergo standardized SWE measurement under controlled conditions. Age-specific and sex-specific reference ranges will be analyzed, which may contribute to enhancing the clinical utility of SWE in pediatric practice.

Enrollment: 450 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged 0-18 years, with no known liver or spleen pathology. Participants must have written consent from their parents or guardians.

Exclusion criteria

• Children with any known liver or spleen disease, including hepatitis, cirrhosis, splenomegaly, or any history of liver and spleen disease. Children outside the age range of 0-18 years.

Trial design

450 participants in 1 patient group

Healthy Children

Description:

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.