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Recruiting Observational

Direct Portal Pressure Measurement Via Endoscopic Ultrasound in Advanced Chronic Liver Disease (EVADIPP)

NCT06266260 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-09-11
Last updated
2025-03-14

Condition(s) studied

Portal Hypertension

Investigational drug(s) / intervention(s)

EUS PPG measurement

EUS PPG measurement: Direct EUS PPG measurement

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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) — 24 months
    The investigators will measure portal pressure gradient through EUS-PPG measurement at baseline and after NSBBs titration in enrolled patients.
  • HVPG Measurement Before and After NSBB Titration in Portal Hypertension — 24 months
    The investigators will measure portal pressure gradient through HVPG measurement at baseline and after NSBBs titration in enrolled patients.

Trial sites (1)

FacilityCityRegionStatus
Policlinico Gemelli IRCCS Roma Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06266260 on ClinicalTrials.gov ↗ ← All trials in Italy