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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis; Portal Hypertension; Non-Cirrhotic Portal Hypertension; EUS; HVPG; Hepatic Venous Pressure Gradient
• Intervention / Treatment: Procedure: Hepatic venous pressure gradient measurement; Procedure: Endoscopic ultrasound-guided portal pressure gradient measurement

Detailed Description

Portal hypertension is one of the most severe complications of advanced chronic liver disease. Direct measurement of portal vein pressure is challenging and does not reliably reflect liver parenchymal resistance. To address this, the portal pressure gradient (PPG) - the difference between portal vein and hepatic vein pressures - is commonly used. The PPG not only predicts the risk of hepatic decompensation and hepatocellular carcinoma development but also correlates with overall patient survival. Conversely, reducing PPG is associated with an improved prognosis. PPG evaluation plays a crucial role in determining the feasibility of hepatic resection for liver cancer in patients with cirrhosis. Given the shortage of liver donors in developed countries, the need for bridging therapies has grown. Hepatic resection can serve either as a curative or a bridging modality; however, the risk of post-resection liver failure is significantly increased in patients with clinically significant portal hypertension. Therefore, PPG measurement is a valuable tool for stratifying patients who may require primary liver transplantation. Traditionally, PPG is indirectly measured using hepatic vein catheterization with measurement of hepatic venous pressure gradient (HVPG). This minimally invasive procedure 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. 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.

Despite its potential, EUS-PPG measurement raises concerns regarding its suitability as a full replacement for HVPG. Proponents of EUS-PPG highlight several advantages, including its minimally invasive nature, excellent safety profile, high technical success rate, the possibility of a "one-stop shop" approach (combining EUS-PPG, liver biopsy, and endoscopic treatment of esophageal varices), absence of radiation exposure, and real-time measurement capability. However, these claimed advantages may not significantly surpass those of HVPG. When performed by experienced operators, HVPG offers comparable safety and technical success rates. It also allows liver biopsy during the same session and provides real-time pressure measurements. Additionally, HVPG facilitates the identification of intrahepatic portosystemic shunts that might affect pressure readings, with the immediate option to repeat measurements in alternative locations. Importantly, HVPG remains feasible in patients with significant ascites, a scenario where EUS-PPG might encounter limitations. The primary question is whether EUS-PPG provides measurements really equivalent to HVPG in terms of gradient accuracy. Significant concerns remain regarding the impact of sedation required for EUS-PPG. Sedatives, particularly widely used propofol, have been shown to influence portal pressure measurements, resulting in obtained lower values. This sedation-induced variability could lead to misclassification of portal hypertension severity, particularly in patients with borderline values, potentially altering clinical decision-making. In this study, we propose a novel design to directly compare two methods-HVPG and EUS-PPG- within a single session, with a specific emphasis on quantifying the impact of sedation on pressure measurements and minimizing potential confounding factors. Patients 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. This sequential approach will enable a direct comparison of all three measurements under standardized conditions, maximizing the reduction of potential bias from unintended repetition of measurements to align with prior pressure readings. Statistical analysis will be performed to evaluate the consistency between the methods and to assess the specific impact of sedation on pressure gradients. This study design aims to provide robust evidence regarding the accuracy and clinical applicability of EUS-PPG relative to HVPG, while addressing the potential confounding effects of anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petr Urbánek, Prof.; Email: petr.urbanek@uvn.cz
• Study Contact Backup: Name: Petr Hříbek, MD, PhD; Phone Number: +420973203065; Email: petr.hribek@uvn.cz

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • IKEM
    • Contact: Tomáš Hucl, Prof.; Phone Number: +420236054016; Email: tomas.hucl@ikem.cz
    • Principal Investigator: Tomáš Hucl, Prof.
    • Sub-Investigator: Tomáš Nesnídal, MD
  • Bohemia
    • Prague, Bohemia, Czechia, 16902
      • Recruiting
      • Military University Hospital Prague
      • Contact: Petr Hříbek, MD, PhD; Phone Number: +420973203065; Email: petr.hribek@uvn.cz
      • Principal Investigator: Petr Hříbek, MD, PhD
      • Sub-Investigator: Petr Urbánek, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants; 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; 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.; Procedure: Endoscopic ultrasound-guided portal pressure gradient measurement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of influence of sedation on measurements	The secondary objective is to evaluate the precise influence of sedation on EUS-PPG results compared to HVPG performed in both conscious and sedated states.	30 days from enrollment

Collaborators and Investigators

• Sponsor: Military University Hospital, Prague
• Collaborators: University Hospital Prague (IKEM), Prague, Czech Republic
• Investigators: Principal Investigator: Petr Hříbek, MD, PhD, Military University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: portal hypertension; liver cirrhosis; HVPG; EUS-PPG
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: 108/20-17/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No