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NCT Number: NCT07365709

Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension

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.

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Key information

Conditions

Portal Hypertension Cirrhosis Digestive System Diseases Fibrosis Hemic and Lymphatic Diseases Hypertension, Portal Liver Diseases Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spleen Disease Splenic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SonoVue

Drug

microbubbles infusion and ultrasound

Other names: INN-sulphur hexafluoride

Primary outcomes

  1. Primary endpoint

    Time frame: 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 outcomes

  1. Secondary endpoint

    Time frame: 12 months

    The determination of the ideal cut-off point

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrizio Pizzolante, MD Phd

CONTACT

[email protected]

+390630159650

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: CIRCE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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