Clinical trial NCT06863012: EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Official title: EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Hypertension
Chronic Liver Disease (CLD)
Cirrhosis
Keywords: Hepatic Venous Pressure Gradient
Endoscopic Ultrasound-Guided Portal Pressure Gradient
Portal hypertension
Non-Invasive Diagnostic Methods for Portal Hypertension
Lead sponsor: Fundacio Privada Mon Clinic Barcelona
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: