Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension (CIRCE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Portal Hypertension; Cirrhosis; Spleen Disease

Treatments: Drug: SonoVue

Study type: Interventional

Funder types: Other

Identifiers

NCT07365709

8138

Details and patient eligibility

About

Portal hypertension is a major complication of cirrhosis. HVPG is the diagnostic gold standard but is invasive. Non-invasive tools such as spleen stiffness measurement (SSM) and CEUS show promise for assessing CSPH, though they have not yet been compared directly. A multimodal ultrasound approach may provide a reliable alternative to HVPG.

Enrollment: 107 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individuals of both sexes aged 18 years or over; Subjects diagnosed with liver cirrhosis. Subjects who have undergone hepatic venous pressure gradient (HVPG) measurement to assess portal hypertension, and/or show indirect clinical signs of significant portal hypertension, such as oesophageal varices or porto-systemic collateral circulation.

Cirrhotic subjects who must undergo contrast-enhanced ultrasound as part of regular hepatological follow-up.

Subjects who have given their informed consent.

Exclusion criteria

Subjects aged under 18 years; Subjects with cholestatic disease Subjects diagnosed with clinically significant portal hypertension of non-cirrhotic aetiology.

Subjects diagnosed with ascites Subjects diagnosed with splanchnic thrombosis Subjects presenting with spleno-portal flow reversal Subjects who are allergic to ultrasound contrast media Subjects who have not given their informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Cirrhosis

Experimental group

Description:

Adult participants (≥18 years old) with clinically confirmed liver cirrhosis, classified as Child-Pugh class A-C, with clinical and morphological signs of portal hypertension

Treatment:

Drug: SonoVue