Evaluation of Elastosonographic Techniques Implemented on Ultrasound Systems for the Assessment of Liver Stiffness

The assessment of liver stiffness is essential in patients with suspected or confirmed chronic liver disease, as clinical management depends on the degree and progression of hepatic fibrosis, which increases liver hardness. In recent years, non-invasive elastosonographic techniques have been introduced to estimate liver fibrosis. The first to be implemented was Transient Elastography (TE), which has shown high accuracy in identifying significant fibrosis and cirrhosis, particularly in patients with HCV-related chronic liver disease, and has been endorsed by The European Association for the Study of the Liver (EASL) guidelines as an alternative to liver biopsy. More recently, shear-wave elastography techniques integrated into conventional ultrasound systems have been developed, offering the advantage of real-time B-mode ultrasound guidance. The aim of this study is to compare these techniques with each other and with TE.

Study Overview

• Status: Completed
• Conditions: Liver Stiffness
• Intervention / Treatment: Diagnostic test: elastosonographic

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years, ability to hold breath during image acquisition, informed consent.

Exclusion Criteria:

• any condition that, in the investigator's clinical judgment, would make further participation in the study unacceptable for that individual patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Age > 18 years cohort	Diagnostic test: elastosonographic; Measurement performed in the right intercostal space, using the median value of 5 measurements for 2D shear wave and 10 measurements for point shear wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
elastosonographic	Measurement taken in the right intercostal space, median value of 5 measurements for 2D shear wave and 10 measurements for point shear wave.	up to 24 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: p_12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No