Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients

The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Hypertension, Portal Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven, Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.

Exclusion criteria

Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
Patient is unwilling or unable to sign and date the informed consent
Patient is unwilling to comply with the follow-up study schedule
Previous total or partial splenectomy
Non-cirrhotic portal hypertension
Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
Patients with known infection which is not controlled by medical intervention
Portopulmonary hypertension
Cardiac decompensation
Pre-sinusoidal liver disease
Cholestatic liver disease
Patient who received endoscopic treatment for upper gastrointestinal (GI) variceal bleeding within the past 7 days
Patients with current hepatocellular carcinoma (HCC)

Treatment and study plan

EchoTip® Insight™

Device

Patients will undergo procedure where HVPG is obtained under mild sedation, next the patients will undergo anesthesia and mechanical intubation where HVPG measurements will be obtained simultaneously with the EchoTip Insight measurement. For patients receiving a transjugular intrahepatic portosystemic shunt (TIPS), direct portal vein pressure measurements will be obtained by the EchoTip® Insight™ and compared to the transjugular direct portal vein measurement obtained during the interventional radiology (IR) procedure.

Primary outcomes

The correlation between the direct and indirect procedures to measure PPG.

Time frame: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours

Under general anesthesia, to quantify the correlation between the calculated PPG from the EchoTip® Insight™ direct measurements (difference between direct portal vein pressure and direct hepatic vein pressure) and indirect HVPG measurement (difference between transjugular free hepatic venous pressure (FHVP) and wedge hepatic venous pressure (WHVP) obtained during an IR procedure.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Aug 3, 2021
Registry last updated: Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed