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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMilitary University Hospital, Prague

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Military University Hospital, Prague

Lead sponsor

University Hospital Prague (IKEM), Prague, Czech Republic

Collaborator