Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension (CIRCE)

January 16, 2026 updated by: Pizzolante Fabrizio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cirrhosis
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
Drug: SonoVue
microbubbles infusion and ultrasound
Other Names:
  • INN-sulphur hexafluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Fabrizio Pizzolante, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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