Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder

NCT07492862 | Not Yet Recruiting

• 1 other identifier: 8071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Currently, diagnosis of this condition necessarily requires a liver biopsy and, despite some differences detected on imaging studies-and particularly on liver and spleen elastography-PSVD remains indistinguishable from cirrhosis using non-invasive tests. Contrast-enhanced ultrasound (CEUS) is an easy-to-perform, repeatable, and cost-effective examination that enables real-time assessment of parenchymal or focal liver lesion perfusion. Moreover, the application of dynamic contrast-enhanced ultrasound (DCE-US-i.e., contrast-enhanced ultrasound followed by quantitative perfusion analysis using dedicated software, such as the VueBox Software that will be used in this study) allows integration of CEUS qualitative assessment with quantitative evaluation of tissue perfusion through analysis of time-intensity curves generated during contrast transit. From this analysis, several perfusion-related parameters can be derived (for example, peak enhancement, time to peak, or area under the curve), which have already proven useful in improving differential diagnosis of focal liver lesions and in predicting treatment response and systemic therapy outcomes. To date, the use of DCE-US for the diagnosis of PSVD has not yet been described; however, based on the underlying histological alterations associated with this disease, it is reasonable to hypothesize that parameters obtained with this technique in the liver parenchyma of patients with PSVD may differ from those measured in patients with liver cirrhosis. The aim of the present project is to apply DCE-US in patients with PSVD and in patients with cirrhosis to evaluate potential significant differences in perfusion parameters, and to assess the feasibility of a non-invasive differential diagnosis between the two conditions using this technique in combination with elastography and bidimensional ultrasound data to develop a multiparametric diagnostic score.

Conditions

Porto-sinusoidal Vascular Liver Disorder; Liver Cirrhosis; Portal Hypertension, Noncirrhotic; Portal Hypertension Related to Cirrhosis; Ultrasound Elastography; Contrast-enhanced Ultrasound

Keywords

porto-sinusoidal vascular liver disorder; liver cirrhosis; liver ultrasound; ultrasound elastography; dynamic contrast-enhanced ultrasound; chronic liver disease

Outcome Measures

Primary Outcomes (7)

• Peak enhancement (PE) measured on DCE-US (VueBox)

  Maximum intensity of the signal in the time-intensity curve at dynamic contrast-enhanced ultrasound

  Baseline

• Time to peak (TTP) measured on DCE-US (VueBox)

  The time required from the beginning of the exam to reach the peak enhancement

  Baseline

• Area under the time-intensity curve (AUC) measured on DCE-US (VueBox)

  The total area under the time-intensity curve reflecting the quantity of contrast media passed through the region of interest

  Baseline

• Wash-in rate (slope) measured on DCE-US (VueBox)

  Tangent at the ascending part of the time-intensity curve

  Baseline

• Mean Transit Time measured on DCE-US (VueBox)

  Mean time taken by contrast to pass through the ROI

  Baseline

• Rise Time measured on DCE-US (VueBox)

  Time from peak enhancement to point where tangent of ascending curve across x-axis

  Baseline

• Wash-out rate measured on DCE-US (VueBox)

  The tangent at the descending part of the time-intensity curve

  Baseline

Secondary Outcomes (5)

• Diagnostic sensitivity and specificity of predefined perfusion parameter cut-offs for identifying PSVD (ROC analysis)

  Baseline

• Performance of a multiparametric diagnostic score combining DCE-US parameters, liver stiffness, spleen stiffness, and B-mode ultrasound features

  Baseline

• Correlation between quantitative DCE-US parameters and risk of portal vein thrombosis at 12 months.

  from enrollement to 12 months

• Incidence of portal vein thrombosis at 12 months

  From baseline to 12 months

• Incidence of disease-related complications (ascites decompensation, hepatic encephalopathy, variceal bleeding) at 12 months in both arms

  From enrollement to 12 months

Study Arms (2)

PSVD (Porto-Sinusoidal Vascular Disorder)

EXPERIMENTAL

Participants with confirmed porto-sinusoidal vascular disease undergoing DCE-US with quantitative perfusion analysis using the VueBox software device

Device: Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software

Cirrhosis

EXPERIMENTAL

Participants with confirmed liver cirrhosis undergoing DCE-US with quantitative perfusion analysis using the VueBox software device

Device: Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software

Interventions

Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software DEVICE

Patients from the two arms will undergoing dynamic contrast-enhanced ultrasound, and CEUS videoclips will be analyzed through the software VueBox to evaluate perfusion parameters. These parameters will be compared among the two arms and integrated with other ultrasound-derived data to analyze differences and to elaborate a multiparametric diagnostic score

Cirrhosis; PSVD (Porto-Sinusoidal Vascular Disorder)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of porto-sinusoidal vascular disease (PSVD);
• Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding);
• Age ≥ 18 years;
• Ability to understand the study information and provide written informed consent;
• Diagnosis of liver cirrhosis confirmed by liver histology or, alternatively, by compatible findings on imaging, laboratory tests, and physical examination together with a positive history for at least one known cause of chronic liver disease;
• Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding);
• Age ≥ 18 years;
• Ability to understand the study information and provide written informed consent.

You may not qualify if:

• Presence of other causes of portal hypertension, including but not limited to: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, or chronic cholestatic liver diseases;
• Presence of portal, spleno-mesenteric, or hepatic vein thrombosis;
• Prior hepatic or splenic surgery;
• Presence of primary or secondary malignant liver tumors;
• Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device;
• Congenital anomalies of the liver or biliary tract;
• History of heart failure;
• Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome;
• Inadequate sonographic visualization of the right hepatic lobe;
• Pregnancy.
• Decompensated cirrhosis or Child-Pugh class C;
• Cryptogenic cirrhosis;
• Presence of portal, spleno-mesenteric, or hepatic vein thrombosis;
• Prior hepatic or splenic surgery;
• Presence of primary or secondary malignant liver tumors;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Assunta Zocco

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Assunta Zocco

CONTACT

+39 0630155057; mariaassunta.zocco@policlinicogemelli.it; raffaele.borriello@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-02

Locations

IT (1)