Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
SonoVue
Drugmicrobubbles infusion and ultrasound
Treatment groups
107 Participants
are divided into 1 treatment groupGroup A: CirrhosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
Secondary endpoint
The determination of the ideal cut-off point
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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