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

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study

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 Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Device: EchoTip® Insight™

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
• Netherlands
  • Rotterdam, Netherlands, NL-3015 CE
    • Erasmus University Medical Center
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic, Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis who have been referred for a HVPG procedure.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours

Collaborators and Investigators

• Sponsor: Cook Research Incorporated
• Investigators: Principal Investigator: Schalk Van der Merwe, Prof, Department of Gastroenterology and Hepatology and Department of Clinical and Experimental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Liver Diseases; Portal Hypertension; End Stage Liver Disease; Hepatic Vein Pressure Gradient; Portal Pressure Measurement; Portal Pressure Gradient; Intractable ascites
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 16-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No