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

Cook Research Incorporated35 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Cirrhosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (3)

University Hospitals Leuven

Leuven, Belgium

Erasmus University Medical Center

Rotterdam, Netherlands

Hospital Clinic, Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.