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NCT Number: NCT06266260

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

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.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

Francesco Santopaolo, MD

CONTACT

[email protected]

+393492754288

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS PPG measurement

Device

Direct EUS PPG measurement

Primary outcomes

  1. 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)

    Time frame: 24 months

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

  2. HVPG Measurement Before and After NSBB Titration in Portal Hypertension

    Time frame: 24 months

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

Secondary outcomes

  1. Markers of hemodynamic response

    Time frame: 24 months

    Spleen Stiffness Measurement (SSM) will be assessed by transient elastography before starting NSBB and using a FibroScan® (Echosens, Paris, France) after an overnight fasting.

  2. Identifying Markers of Hemodynamic Response in Portal Hypertension

    Time frame: 24 months

    Liver Stiffness Measurement (LSM) will be assessed by transient elastography before starting NSBB and using a FibroScan® (Echosens, Paris, France) after an overnight fasting.

  3. Clinical and Biochemical Indicators of Hemodynamic Response

    Time frame: 24 months

    The gut microbiota will be collected before and after the start of therapy with NSBBs. Fecal samples will be collected at home in a commercial sterile, dry screw-top container, and frozen at -80 °C within 24 hours, until further processing. Baseline and post NSBBs treatment blood samples collected from portal vein will be drawn, processed and stored at -80°C within 1 hour, until further processing.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabetta Creta, SC

CONTACT

[email protected]

Francesco Santopaolo, MD

CONTACT

[email protected]

+393492754288

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluation of Direct Portal Pressure Measurement by Endoscopic Ultrasound in Advanced Chronic Liver Disease and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)

Acronym: EVADIPP

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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