Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07365709
Status
Not Yet Recruiting

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Conditions

  • Cirrhosis
  • Portal Hypertension
  • Spleen Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SonoVue — DRUG
    microbubbles infusion and ultrasound

Study Details

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.

Key Dates

First listed
Jan 26, 2026
Start date
Feb 1, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
107 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

Primary endpoint [ Time Frame: 12 months ]

Central Contacts

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