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

NCT06863012 · Fundacio Privada Mon Clinic Barcelona
In plain English

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