RecruitingNot Applicable

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

Czechia40 participantsStarted 2025-05-30

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Evaluation of the consistency between the HVPG and EUS-PPG

Timeframe: 30 days after enrollment

Trial details

NCT IDNCT07424963

SponsorMilitary University Hospital, Prague

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Petr Hříbek, MD, PhD

+420973203065 petr.hribek@uvn.cz