← Back to searchRecruitingRecruiting
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
NCT06863012 · Fundacio Privada Mon Clinic Barcelona
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-16
Estimated completion: 2025-12
Last updated: 2025-08-12
Interventions
Diagnostic Test: Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) MeasurementDiagnostic Test: Hepatic Venous Pressure Gradient (HVPG) Measurement
Primary outcomes
- • 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)
Sponsor
Fundacio Privada Mon Clinic Barcelona · other
All locations (1)
Hospital Clinic de BarcelonaRecruiting
Barcelona, Barcelona, Spain