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

NCT ID: NCT07302152

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-16

Study Completion Date

2025-05-05

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Stiffness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Age > 18 years cohort

Group Type OTHER

elastosonographic

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Gianluigi Poma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Pavia, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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p_12

Identifier Type: -

Identifier Source: org_study_id