Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06863012

EUS-guided Portal Pressure Gradient Measurement as a Potential Alternative to Traditional HVPG in Portal Hypertension

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

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new method called endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) test in adults with portal hypertension caused by chronic liver disease and cirrhosis. This study aims to determine how well EUS-PPG correlates with HVPG, whether it can serve as a reliable and less invasive option, and to assess the safety outcomes of EUS-PPG compared to HVPG. Participants will undergo both EUS-PPG and HVPG measurements within a seven-day period to allow direct comparison. The EUS-PPG procedure uses an endoscopic ultrasound probe and a fine-needle aspiration needle to directly measure portal pressure without requiring catheterization, radiation, or contrast agents. The HVPG measurement involves catheterizing the hepatic vein using fluoroscopy and specialized radiology equipment. Researchers will compare these two diagnostic tests to assess accuracy, feasibility, and safety. During the study, adults aged 18 to 85 with a history of liver disease and portal hypertension or suspected cirrhosis will provide demographic and clinical data including liver disease history, Child-Pugh and MELD scores, and complications like varices or ascites. Safety monitoring will include tracking adverse events such as bleeding, infection, or perforation. The main outcome is the correlation between pressure measurements from EUS-PPG and HVPG taken within 7 days. Participants will continue to receive standard care for their liver condition throughout the study period.

CONDITIONS

Brief 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 informed 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
  • Use of blood thinners within the last 5 days
  • Massive ascites causing abdominal swelling or requiring frequent paracentesis
  • Previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or surgical portosystemic 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 with echoendoscope

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 7 days

Participants undergo two diagnostic procedures to measure portal pressure: Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) measurement and Hepatic Venous Pressure Gradient (HVPG) measurement. These procedures assess portal hypertension in patients with chronic liver disease.

1 to 2 visits (in-person) depending on scheduling of procedures

Follow-up

Duration - Up to 7 days after diagnostic evaluation

Participants are monitored after the diagnostic procedures to assess safety and outcomes.

1 visit (in-person)

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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