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

NCT07424963 | Recruiting

• 1 other identifier: 108/20-17/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cirrhosis; Portal Hypertension; EUS; Non-Cirrhotic Portal Hypertension; HVPG; Hepatic Venous Pressure Gradient

Keywords

HVPG; EUS-PPG; portal hypertension; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the consistency between the HVPG and EUS-PPG

  The primary objective of this project is to determine whether EUS-PPG is fully comparable to HVPG in terms of accuracy. This will be assessed through a direct, one-session comparison of measurements obtained by both methods.

  30 days after enrollment

Secondary Outcomes (1)

• Evaluation of influence of sedation on measurements

  30 days from enrollment

Study Arms (1)

Participants

EXPERIMENTAL

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.

Procedure: Hepatic venous pressure gradient measurement; Procedure: Endoscopic ultrasound-guided portal pressure gradient measurement

Interventions

Hepatic venous pressure gradient measurement PROCEDURE

HVPG measurement is minimally invasive procedure that involves cannulation of the right internal jugular vein, followed by the insertion of a balloon-occlusion catheter into the right or middle hepatic vein to measure both free hepatic vein pressure and wedged hepatic vein pressure, enabling the calculation of HVPG. Additionally, this method allows for liver biopsy during the same session. HVPG is widely regarded as the gold standard for PPG measurement.

Participants

Endoscopic ultrasound-guided portal pressure gradient measurement PROCEDURE

Recent advancements in the field of digestive endoscopy have introduced an innovative alternative: endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement. This emerging technique shows promise for further improving the accessibility of portal hypertension assessment and also offers the possibility of liver biopsy in one session. EUS-PPG may have several advantages, including its minimally invasive nature, safety profile, high technical success rate, the possibility of a "one-stopshop" approach (combining EUS-PPG, liver biopsy, and endoscopic treatment of esophageal varices), absence of radiation exposure.

Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Military University Hospital, Prague: lead
• University Hospital Prague (IKEM), Prague, Czech Republic: collaborator

Study Sites (2)

Military University Hospital Prague

Prague, Bohemia, 16902, Czechia

RECRUITING

IKEM

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Petr Hříbek, MD, PhD

  Military University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Hříbek, MD, PhD

CONTACT

+420973203065; petr.hribek@uvn.cz

Petr Urbánek, Prof.

CONTACT

petr.urbanek@uvn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 20, 2026
• Study Start: May 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-01

Locations

CZ (2)