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

NCT04987034 | Completed

• 1 other identifier: 16-11
• Study Type: observational
• Target: 35
• Locations: 3 countries
• Sites: 3

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.

Conditions

Liver Cirrhosis

Keywords

Portal Pressure Measurement; Portal Pressure Gradient; Hepatic Vein Pressure Gradient; Liver Diseases; Portal Hypertension; Intractable ascites; End Stage Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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™

Interventions

EchoTip® Insight™ DEVICE

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.

Direct and indirect PPG measurements

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (3)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Erasmus University Medical Center

Rotterdam, NL-3015 CE, Netherlands

Location

Hospital Clinic, Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• Vanderschueren E, Laleman W, Bonne L, Maleux G, Wagner DR, Yeh C, Calvo A, Sendino O, Gines A, Baiges A, Bruno MJ, Garcia-Pagan JC, van der Merwe S. Endoscopic ultrasound-guided portosystemic pressure gradient measurement vs. transjugular balloon occlusion measurement in patients with cirrhosis (ENCOUNTER): A bicentric EU study. JHEP Rep. 2025 May 29;7(8):101466. doi: 10.1016/j.jhepr.2025.101466. eCollection 2025 Aug.

  PMID: 40689144 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases; Hypertension, Portal; End Stage Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency

Study Officials

• Schalk Van der Merwe, Prof

  Department of Gastroenterology and Hepatology and Department of Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: July 27, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

ES (1); NL (1); BE (1)