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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-27

Study Completion Date

2023-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Direct and indirect PPG measurements

Measuring the portalsystemic pressure gradient in patients directly using the EchoTip® Insight™ and indirectly through the HVPG procedure.

EchoTip® Insight™

Intervention Type 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.

Interventions

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EchoTip® Insight™

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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No