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

RecruitingNAAges 18 Years - 85 YearsAllFundacio Privada Mon Clinic Barcelona
NCT06863012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 red

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📋 Eligibility rules (as published)
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.
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What it tests

  • Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement
  • Hepatic Venous Pressure Gradient (HVPG) Measurement
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Where

1 site
Hospital Clinic de Barcelona
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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