Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension

Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension: the Role of Contrast-enhanced Ultrasound and Splenic Elastography for Non-invasive Assessment

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07365709

Acronym

CIRCE

Enrollment

107

Registered

2026-01-26

Start date

2026-02-01

Completion date

2026-12-31

Last updated

2026-01-26

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

Conditions

Portal Hypertension, Spleen Disease, Cirrhosis

Brief summary

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.

Interventions

DRUGSonoVue

microbubbles infusion and ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary endpoint	12 months	evaluate the diagnostic performance between the selected parameters and the gold standard for assessing portal hypertension, i.e., HVPG using the ROC curve and calculation of sensitivity, specificity, VPP, VPN, and AUC. Bland-Altman analysis will be applied to assess concordance.

Secondary

Measure	Time frame	Description
Secondary endpoint	12 months	The determination of the ideal cut-off point

Contacts

CONTACTFabrizio Pizzolante, MD Phd

fabrizio.pizzolante@policlinicogemelli.it+390630159650

PRINCIPAL_INVESTIGATORFabrizio Pizzolante

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Outcome results

None listed

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