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

NCT ID: NCT06266260

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2026-04-01

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.

Detailed Description

Specific Aim 1 To explore the correlation between endoscopic ultrasound (EUS)-guided portal pressure gradient (PPG) and hepatic venous pressure gradient (HVPG) in evaluation of hemodynamic response to non-selective beta blockers (NSBBs) in patients with advanced chronic liver disease and high risk varices. The investigators will perform EUS-PPG measurement and HVPG measurement at baseline and after NSBBs titration in enrolled patients. Hemodynamic response to medical therapy is defined as either a decrease in HVPG by >20% of the baseline value or an absolute value of HVPG < 12 mmHg after dose titration.

Correlation between PPG/HVPG values and development of portal hypertension-related gastrointestinal bleeding or liver- related events (ascites, spontaneous bacterial peritonitis, and hepatic encephalopathy) will be clinically assessed during follow-up with outpatients visits every 2-3 months.

Specific Aim 2 Identification of other markers of hemodynamic response to non selective beta blockers (NSBBs), with focus on elastography modifications and gut microbiota composition. To identify predictors of hemodynamic response, splenic and hepatic elastography measurement will performed at baseline and after NSBBs titration. In the same way the investigators will evaluate the gut microbiota before and after the start of therapy with NSBBs.

Specific Aim 3 Identification of factors potentially affecting the accuracy of PPG measurement. It is well-known that deep sedation may cause inaccurate HVPG values, while mild sedation with low dose midazolam does not modify the HVPG. In a subgroup of enrolled patients the investigators will perform PPG measurement with deep and mild sedation in order to investigate influence of deep sedation on PPG measurement accuracy.

Conditions

Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

EUS PPG measurement

Direct EUS PPG measurement

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Santopaolo Francesco

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Santopaolo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico A. Gemelli IRCCS, Rome

Locations

Policlinico Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Santopaolo, MD

Role: CONTACT

francesco.santopaolo@policlinicogemelli.it

+393492754288

Elisabetta Creta, SC

Role: CONTACT

elisabetta.creta@policlinicogemelli.it

Facility Contacts

Francesco Santopaolo, MD

Role: primary

francesco.santopaolo@policlinicogemelli.it

+393492754288

Other Identifiers

5486

Identifier Type: -

Identifier Source: org_study_id