Portal Hypertension Clinical Trial
— EVADIPPOfficial title:
Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
NCT number | NCT06266260 |
Other study ID # | 5486 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 11, 2023 |
Est. completion date | April 1, 2026 |
A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Patients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests (porto- systemic collaterals at imaging, platelet count <150.000 x mm3, spleen size >13 cm in the largest axis, alteration of elastography parameters of the liver or spleen) - naïve to treatment with NSBBs, Exclusion Criteria: - Child Pugh >A6 - Hepatocellular carcinoma - Portal vein thrombosis |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Gemelli IRCCS | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) | The investigators will measure portal pressure gradient through EUS-PPG measurement at baseline and after NSBBs titration in enrolled patients. | 24 months | |
Primary | Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) | The investigators will measure portal pressure gradient through HVPG measurement at baseline and after NSBBs titration in enrolled patients. | 24 months | |
Secondary | Markers of hemodynamic response | Spleen Stiffness Measurement (SSM) will be assessed by transient elastography before starting NSBB and using a FibroScan® (Echosens, Paris, France) after an overnight fasting. | 24 months | |
Secondary | Markers of hemodynamic response | Liver Stiffness Measurement (LSM) will be assessed by transient elastography before starting NSBB and using a FibroScan® (Echosens, Paris, France) after an overnight fasting. | 24 months | |
Secondary | Markers of hemodynamic response | The gut microbiota will be collected before and after the start of therapy with NSBBs. Fecal samples will be collected at home in a commercial sterile, dry screw-top container, and frozen at -80 °C within 24 hours, until further processing. Baseline and post NSBBs treatment blood samples collected from portal vein will be drawn, processed and stored at -80°C within 1 hour, until further processing. | 24 months |
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