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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Device: EchoTip® Insight™


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Direct and indirect PPG measurements<br>Measuring the portalsystemic pressure gradient in patients directly using the EchoTip® Insight™ and indirectly through the HVPG procedure. | Device: EchoTip® Insight™<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between the direct and indirect procedures to measure PPG. | 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. | The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Portal Pressure Measurement, Portal Pressure Gradient, Hepatic Vein Pressure Gradient, Liver Diseases, Portal Hypertension, Intractable ascites, End Stage Liver Disease