NCT06266260 Direct Portal Pressure Measurement Via Endoscopic Ultrasound in Advanced Chronic Liver Disease (EVADIPP)
| NCT ID | NCT06266260 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Portal Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-09-11 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Francesco Santopaolo, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico A. Gemelli IRCCS, Rome
Frequently Asked Questions
Who can join the NCT06266260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Portal Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06266260 currently recruiting?
Yes, NCT06266260 is actively recruiting participants. Contact the research team at francesco.santopaolo@policlinicogemelli.it for enrollment information.
Where is the NCT06266260 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06266260 clinical trial?
NCT06266260 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Francesco Santopaolo, MD at Fondazione Policlinico A. Gemelli IRCCS, Rome. The trial plans to enroll 50 participants.