Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SonoVue.
- Who it may be relevant to
- Registry conditions: Portal Hypertension, Spleen Disease, Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension: the Role of Contrast-enhanced Ultrasound and Splenic Elastography for Non-invasive Assessment
Overview
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
- Drug SonoVue
microbubbles infusion and ultrasound
Primary outcome measures
- Primary endpoint [Time frame: 12 months]
Secondary outcome measures (1)
- Secondary endpoint [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07365709 · 8138