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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07302152
Enrollment
72
Registered
2025-12-24
Start date
2023-03-16
Completion date
2025-05-05
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Stiffness

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.

Interventions

DIAGNOSTIC_TESTelastosonographic

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

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
elastosonographicup to 24 monthsMeasurement taken in the right intercostal space, median value of 5 measurements for 2D shear wave and 10 measurements for point shear wave.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026