Normal Pediatric Liver and Spleen SWE (SWE)

Normal Liver and Spleen Stiffness Values Using Shear Wave Elastography in Children

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 434

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya
    • Konya, Konya, Turkey (Türkiye), 42130
      • Selçuk University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Shear Wave Elastography; Liver Stiffness; Spleen Stiffness; Pediatric Elastography; Normal Reference Values; Organ Stiffness Measurement
• Other Study ID Numbers: 2024/522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be shared upon request with qualified researchers, following approval from the relevant ethics committee. The data will be anonymized and shared in aggregate form to ensure the confidentiality of participants. The plan for data sharing complies with the ICMJE guidelines for publication in ICMJE journals.

IPD Sharing Time Frame

Start Date: August 2025

End Date: August 2028

• IPD Sharing Access Criteria: Access to the IPD and supporting information will be granted to qualified researchers upon request. The data will be anonymized and shared through a secure online platform, with access granted only after approval from the relevant ethics committee. Only the study protocol, statistical analysis plan, and anonymized individual participant data will be available. Researchers will be required to sign a data use agreement to ensure the confidentiality of the data and the ethical use of the information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No