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Hepatic Venous Pressure Gradient Versus Endoscopic Ultrasound-Guided Portal Pressure Gradient - Comparative Analysis (HEPCA)

RecruitingNAAges 18 Years - 75 YearsAllMilitary University Hospital, Prague
NCT07424963 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this interventional trial is to compare in measuring of portal hypertension by HVPG and EUS-PPG in subject indicated to HVPG measurement. The primary question is whether EUS-PPG provides measurements really equivalent to HVPG in terms of gradient accuracy. Participants undergoing HVPG will first undergo the procedure while conscious, performed by the first operator. Immediately thereafter, HVPG will be repeated following the induction of anesthesia by a second operator blinded to the initial readings. Subsequently, EUS-PPG will be performed by an endoscopist, who will also be blinded to all previous pressure measurements.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-75 years at the time of enrollment; signed informed consent * Clinical indication for HVPG measurement and/or transjugular liver biopsy for chronic advanced liver disease Exclusion Criteria: * Severe co-morbidities (e.g., advanced chronic heart failure, chronic renal insufficiency stage 4 and above, long-term poorly compensated diabetes mellitus with severe complications) * Pregnancy * Estimated patient non-compliance and/or not signing of the informed consent * Documented iodine contrast dye allergy * Presence of portal vein thrombosis or cavernomatous transformation of portal vein or hepatic vein obstruction * Ascites Grade 3 * Biliary obstruction * Anticoagulation or antiplatelet therapy, which cannot be discontinued * INR \> 1.5 and/or platelet count \< 50,000/µl * Hepatocellular carcinoma in the left lobe of the liver * Surgically altered upper gastrointestinal tract anatomy * State after transjugular intrahepatic portosystemic shunt * State after liver transplantation
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What it tests

  • Hepatic venous pressure gradient measurement
  • Endoscopic ultrasound-guided portal pressure gradient measurement
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Where

2 sites
Military University Hospital Prague
Prague, Czechia
IKEM
Prague, Czechia
🤝 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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