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

Cook Group

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Device: EchoTip® Insight™

Study type: Observational

Funder types: Industry

Identifiers

NCT04987034

16-11

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

35 participants in 1 patient group

Direct and indirect PPG measurements

Description:

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

Treatment:

Device: EchoTip® Insight™