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

NCT07302152 | Completed

• 1 other identifier: p_12
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Stiffness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Age > 18 years cohort

OTHER

Diagnostic Test: elastosonographic

Interventions

elastosonographic DIAGNOSTIC_TEST

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

Age > 18 years cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia

Pavia, Pavia, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 24, 2025
• Study Start: March 16, 2023
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-02

Locations

IT (1)