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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987034
• Other study ID #: 16-11
• Status: Completed
• Start date: July 27, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Netherlands	Erasmus University Medical Center	Rotterdam
Spain	Hospital Clinic, Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

Belgium,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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