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

Not Applicable

Not yet recruiting

• Conditions: Portal Hypertension; Chronic Liver Disease (CLD); Cirrhosis

• Registration Number: NCT06863012
• Lead Sponsor: Fundacio Privada Mon Clinic Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).	7 days	Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) using the EchoTip® Insight™ needle and the hepatic venous pressure gradient (HVPG) measured through hepatic vein catheterization in patients with chronic portal hypertension due to liver cirrhosis.