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

  • STATUS
    Recruiting
  • End date
    May 9, 2023
  • participants needed
    45
  • sponsor
    Cook Research Incorporated
Updated on 9 June 2022
anesthesia
venous pressure
cirrhosis
hepatic venous pressure gradient
portosystemic shunt

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.

Details
Condition Liver Cirrhosis
Treatment EchoTip® Insight™
Clinical Study IdentifierNCT04987034
SponsorCook Research Incorporated
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

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)
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