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

Completed

• Conditions: Liver Cirrhosis
• Interventions: Device: EchoTip® Insight™

• Registration Number: NCT04987034
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-27
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-03
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Direct and indirect PPG measurements	EchoTip® Insight™	Measuring the portalsystemic pressure gradient in patients directly using the EchoTip® Insight™ and indirectly through the HVPG procedure.

Primary Outcome Measures

Name	Time	Method
The correlation between the direct and indirect procedures to measure PPG.	The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours	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.

Trial Locations

Locations (3)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Hospital Clinic, Barcelona; 🇪🇸 Barcelona, Spain