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

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

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.

Inclusion Criteria:

• Subjects must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
• Subjects who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
• Subjects capable of giving signed informed consent.

Exclusion Criteria:

• Pregnancy.
• Significant bleeding risk (International Normalized Ratio (INR) > 1.5 OR platelet count < 50000).
• Presence of active gastrointestinal bleeding at the time of screening
• History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
• Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
• Subjects having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
• Hepatocellular carcinoma not meeting Milan Criteria.
• Presence of portal vein thrombosis or another suspected component of presinusoidal portal hypertension.
• Presence of extra-hepatic cancer, terminal disease, or severe comorbidities significantly limiting life expectancy or affecting study participation.
• Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.