Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhosis | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonoVue | Drug | microbubbles infusion and ultrasound |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoint | The determination of the ideal cut-off point | 12 months |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrizio Pizzolante, MD Phd | Contact | +390630159650 | fabrizio.pizzolante@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Pizzolante | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D013158 | Splenic Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C420843 | contrast agent BR1 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |