Normal Pediatric Liver and Spleen SWE

Not yet recruiting

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

• Registration Number: NCT06930066
• Lead Sponsor: Selcuk University

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Study Start: 2025-04-30
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Normal liver and spleen stiffness values	Day 1	This study aims to establish reference values for liver and spleen stiffness in healthy children using shear wave elastography (SWE).