RecruitingNot ApplicableNCT07424963

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

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

Sponsor

Military University Hospital, Prague

Enrollment

40 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

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 Criteria13

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

Interventions

PROCEDUREHepatic 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.

PROCEDUREEndoscopic 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.