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

Sponsor
Fundacio Privada Mon Clinic Barcelona
Study ID
NCT06863012
Status
Recruiting
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Conditions

  • Chronic Liver Disease (CLD)
  • Cirrhosis
  • Portal Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement — DIAGNOSTIC_TEST
    Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) measurement is a minimally invasive, ultrasound-based diagnostic procedure designed to assess portal hypertension in patients with chronic liver disease. Using an endoscopic ultrasound (EUS) probe, and a fine-needle aspiration (FNA) needle (EchoTip® Insight™) is used to directly measure intravascular pressures. Unlike the standard hepatic venous pressure gradient (HVPG) measurement, EUS-PPG provides direct pressure readings, does not require catheterization of the hepatic vein, and eliminates the need for radiation, iodinated contrast, and interventional radiology. This study aims to evaluate the accuracy, feasibility, and safety of EUS-PPG compared to HVPG.
  • Hepatic Venous Pressure Gradient (HVPG) Measurement — DIAGNOSTIC_TEST
    Hepatic Venous Pressure Gradient (HVPG) measurement is the current gold standard for assessing portal hypertension in patients with chronic liver disease. The procedure involves catheterization of the hepatic vein via the jugular or femoral vein, where free hepatic venous pressure (FHVP) and wedged hepatic venous pressure (WHVP) are measured using a pressure transducer. HVPG is an indirect measure of portal pressure and requires fluoroscopy, radiation exposure, and specialized interventional radiology equipment. While widely used in clinical practice, HVPG has limitations, including the need for a hospital setting, potential patient discomfort, and limited feasibility in certain cases. This study will compare HVPG to EUS-PPG to determine whether EUS-PPG can serve as a less invasive and more accessible alternative.

Study Details

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.

Key Dates

First listed
Mar 7, 2025
Start date
Apr 16, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: EUS-PPG and HVPG Measurement in Portal Hypertension

Primary Outcome Measure

Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG). [ Time Frame: 7 days ]

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