NCT04987034

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-27
• Primary completion: 2023-08-31
• Completion: 2023-09-30
• First posted: 2021-08-03
• Last updated: 2024-01-16

Locations

3 sites across 3 countries: Belgium, Netherlands, Spain