Liver CirrhosisNCT04987034
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
An observational study of Liver Cirrhosis, run by Cook Research Incorporated at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- EchoTip® Insight™
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 27 Jul 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis who have been referred for a HVPG procedure.
Who may be able to join
- Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study
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
- Being tested
- EchoTip® Insight™
- Keywords
- Portal Pressure Measurement, Portal Pressure Gradient, Hepatic Vein Pressure Gradient, Liver Diseases, Portal Hypertension, Intractable ascites, End Stage Liver Disease
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Hypertension, Portal, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Direct and indirect PPG measurements | Measuring the portalsystemic pressure gradient in patients directly using the EchoTip® Insight™ and indirectly through the HVPG procedure. Receives: Device: EchoTip® Insight™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start27 Jul 2021
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Schalk Van der Merwe, Prof, Principal investigator, Department of Gastroenterology and Hepatology and Department of Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987034
- Sponsor's protocol ID
- 16-11
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Publications
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.
PubMed 40689144
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study
- ClinicalTrials.gov ID
- NCT04987034
- Acronym / sponsor ID
- 16-11
- Conditions
- Liver Cirrhosis
- Keywords
- Portal Pressure Measurement, Portal Pressure Gradient, Hepatic Vein Pressure Gradient, Liver Diseases, Portal Hypertension, Intractable ascites, End Stage Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct and indirect PPG measurements | – | Device: EchoTip® Insight™Measuring the portalsystemic pressure gradient in patients directly using the EchoTip® Insight™ and indirectly through the HVPG procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis who have been referred for a HVPG procedure.
Key inclusion criteria (1 listed)
- Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Direct and indirect PPG measurements |
Primary outcome
The correlation between the direct and indirect procedures to measure PPG.
Time frame: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 40689144Vanderschueren 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.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schalk Van der Merwe, Prof principal investigator
Department of Gastroenterology and Hepatology and Department of Clinical and Experimental Medicine
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Cook Research Incorporated at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between the direct and indirect procedures to measure PPG. (time frame: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.