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

Last updated: March 11, 2025
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Liver Disease

Circulation Disorders

Treatment

EUS PPG measurement

Clinical Study ID

NCT06266260
5486
  • Ages 18-99
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with newly diagnosed esophago-gastric varices or with high suspicion ofCSPH 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 elastographyparameters of the liver or spleen)

  • naïve to treatment with NSBBs,

Exclusion

Exclusion Criteria:

  • Child Pugh >A6

  • Hepatocellular carcinoma

  • Portal vein thrombosis

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: EUS PPG measurement
Phase:
Study Start date:
September 11, 2023
Estimated Completion Date:
April 01, 2026

Study 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.

Connect with a study center

  • Policlinico Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

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