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

NCT06266260 | Recruiting

• 1 other identifier: 5486
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

• HVPG Measurement Before and After NSBB Titration in Portal Hypertension

  The investigators will measure portal pressure gradient through HVPG measurement at baseline and after NSBBs titration in enrolled patients.

  24 months

Secondary Outcomes (3)

• Markers of hemodynamic response

  24 months

• Identifying Markers of Hemodynamic Response in Portal Hypertension

  24 months

• Clinical and Biochemical Indicators of Hemodynamic Response

  24 months

Interventions

EUS PPG measurement DEVICE

Direct EUS PPG measurement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive outpatients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests, naïve to treatment with NSBBs, will be evaluated over a two-years period.

You may qualify if:

• 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,

You may not qualify if:

• Child Pugh \>A6
• Hepatocellular carcinoma
• Portal vein thrombosis

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

feces

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Francesco Santopaolo, MD

  Fondazione Policlinico A. Gemelli IRCCS, Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Santopaolo, MD

CONTACT

+393492754288; francesco.santopaolo@policlinicogemelli.it

Elisabetta Creta, SC

CONTACT

elisabetta.creta@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: February 20, 2024
• Study Start: September 11, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

IT (1)