CompletedNot Applicable

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

Belgium, Netherlands, Spain35 participantsStarted 2021-07-27

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The correlation between the direct and indirect procedures to measure PPG.

Timeframe: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours

Trial details

NCT IDNCT04987034

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Liver Cirrhosis trials