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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Liver Stiffness

Treatments: Diagnostic Test: elastosonographic

Study type: Interventional

Funder types: Other

Identifiers

NCT07302152

p_12

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Age > 18 years cohort

Other group

Treatment:

Diagnostic Test: elastosonographic