Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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