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

NCT04987034 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2024-01-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Principal Investigators

  • Schalk Van der Merwe, Prof · Department of Gastroenterology and Hepatology and Department of Clinical and Experimental Medicine

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-08-31
Completion
2023-09-30

Countries

  • Belgium
  • Netherlands
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987034 on ClinicalTrials.gov