Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06863012

EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG

Led by Fundacio Privada Mon Clinic Barcelona · Updated on 2025-08-12

20

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal hypertension due to chronic liver disease. The main questions it aims to answer are: * What is the correlation between EUS-PPG and HVPG measurements in patients with portal hypertension due to cirrhosis? * Can EUS-PPG serve as a reliable and less invasive alternative to HVPG for assessing portal pressure? * What are the safety outcomes associated with EUS-PPG compared to HVPG? Researchers will compare EUS-PPG measurements with HVPG measurements within the same patients to assess whether EUS-PPG provides accurate and clinically comparable portal pressure readings while reducing procedural risks. Participants will: * Be adults aged 18 to 85 with a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement. * Undergo both EUS-PPG and HVPG measurements within a seven-day window to allow for direct comparison of results. * Receive standard clinical care for their condition, including routine diagnostic evaluations and portal hypertension management as needed. * Be monitored for safety outcomes, including adverse events such as bleeding, infection, perforation, and any other complications related to the procedure. * Provide relevant demographic and clinical data, including liver disease history, Child-Pugh and MELD scores, and portal hypertension-related complications such as varices or ascites.

CONDITIONS

Official Title

EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years at the time of consent
  • History of liver disease with portal hypertension or suspected cirrhosis requiring HVPG measurement
  • Ability to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Significant bleeding risk (INR > 1.5 or platelet count < 50000)
  • Active gastrointestinal bleeding at screening
  • Blood thinner use within the last 5 days
  • Massive ascites causing abdominal swelling or needing frequent drainage
  • Previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or surgical shunt
  • Hepatocellular carcinoma not meeting Milan Criteria
  • Portal vein thrombosis or suspected presinusoidal portal hypertension
  • Extra-hepatic cancer, terminal illness, or severe comorbidities limiting life expectancy or study participation
  • Gastrointestinal tract stenosis or surgical changes preventing endoscopic access

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain, 08036

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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