Portal HypertensionEUS-PPGNCT06863012
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
A study testing Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement and Hepatic Venous Pressure Gradient (HVPG) Measurement in people with Portal Hypertension and Chronic Liver Disease (CLD), run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.
Trial summary
The goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Portal Hypertension, Chronic Liver Disease (CLD), Cirrhosis
- What is being tested?
- Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement and Hepatic Venous Pressure Gradient (HVPG) Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 16 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subjects must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
- Subjects who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- Subjects capable of giving signed informed consent.
Who cannot join
- Pregnancy.
- Significant bleeding risk (International Normalized Ratio (INR) > 1.5 OR platelet count < 50000).
- Presence of active gastrointestinal bleeding at the time of screening
- History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
- Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
- Subjects having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
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- Hepatocellular carcinoma not meeting Milan Criteria.
- Presence of portal vein thrombosis or another suspected component of presinusoidal portal hypertension.
- Presence of extra-hepatic cancer, terminal disease, or severe comorbidities significantly limiting life expectancy or affecting study participation.
- Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Principal Investigator, +34932275400, contacta@clinic.cat
Juan Carlos García-Pagan
About this study
The goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal hypertension due to chronic liver disease. The main questions it aims to answer are:
- What is the correlation between EUS-PPG and HVPG measurements in patients with portal hypertension due to cirrhosis?
- Can EUS-PPG serve as a reliable and less invasive alternative to HVPG for assessing portal pressure?
- What are the safety outcomes associated with EUS-PPG compared to HVPG?
Read more
Researchers will compare EUS-PPG measurements with HVPG measurements within the same patients to assess whether EUS-PPG provides accurate and clinically comparable portal pressure readings while reducing procedural risks.
Participants will:
- Be adults aged 18 to 85 with a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- Undergo both EUS-PPG and HVPG measurements within a seven-day window to allow for direct comparison of results.
- Receive standard clinical care for their condition, including routine diagnostic evaluations and portal hypertension management as needed.
- Be monitored for safety outcomes, including adverse events such as bleeding, infection, perforation, and any other complications related to the procedure.
- Provide relevant demographic and clinical data, including liver disease history, Child-Pugh and MELD scores, and portal hypertension-related complications such as varices or ascites.
- Conditions
- Portal Hypertension, Chronic Liver Disease (CLD), Cirrhosis
- Being tested
- Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement, Hepatic Venous Pressure Gradient (HVPG) Measurement
- Keywords
- Hepatic Venous Pressure Gradient, Endoscopic Ultrasound-Guided Portal Pressure Gradient, Portal hypertension, Non-Invasive Diagnostic Methods for Portal Hypertension
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) MeasurementDiagnostic test
Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) measurement is a minimally invasive, ultrasound-based diagnostic procedure designed to assess portal hypertension in patients with chronic liver disease. Using an endoscopic ultrasound (EUS) probe, and a fine-needle aspiration (FNA) needle (EchoTip® Insight™) is used to directly measure intravascular pressures. Unlike the standard hepatic venous pressure gradient (HVPG) measurement, EUS-PPG provides direct pressure readings, does not require catheterization of the hepatic vein, and eliminates the need for radiation, iodinated contrast, and interventional radiology. This study aims to evaluate the accuracy, feasibility, and safety of EUS-PPG compared to HVPG.
Hepatic Venous Pressure Gradient (HVPG) MeasurementDiagnostic test
Hepatic Venous Pressure Gradient (HVPG) measurement is the current gold standard for assessing portal hypertension in patients with chronic liver disease. The procedure involves catheterization of the hepatic vein via the jugular or femoral vein, where free hepatic venous pressure (FHVP) and wedged hepatic venous pressure (WHVP) are measured using a pressure transducer. HVPG is an indirect measure of portal pressure and requires fluoroscopy, radiation exposure, and specialized interventional radiology equipment. While widely used in clinical practice, HVPG has limitations, including the need for a hospital setting, potential patient discomfort, and limited feasibility in certain cases. This study will compare HVPG to EUS-PPG to determine whether EUS-PPG can serve as a less invasive and more accessible alternative.
| Study group | Role | What they receive |
|---|---|---|
| EUS-PPG and HVPG Measurement in Portal Hypertension | Experimental | Not described Receives: Diagnostic Test: Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement; Diagnostic Test: Hepatic Venous Pressure Gradient (HVPG) Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) using the EchoTip® Insight™ needle and the hepatic venous pressure gradient (HVPG) measured through hepatic vein catheterization in patients with chronic portal hypertension due to liver cirrhosis.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start16 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863012
- Sponsor's protocol ID
- EUS-PPG
- Acronym
- EUS-PPG
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
- ClinicalTrials.gov ID
- NCT06863012
- Acronym / sponsor ID
- EUS-PPG / EUS-PPG
- Conditions
- Portal Hypertension, Chronic Liver Disease (CLD), Cirrhosis
- Keywords
- Hepatic Venous Pressure Gradient, Endoscopic Ultrasound-Guided Portal Pressure Gradient, Portal hypertension, Non-Invasive Diagnostic Methods for Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacio Privada Mon Clinic BarcelonaUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Mar 2025 (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 goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal hypertension due to chronic liver disease. The main questions it aims to answer are:
- What is the correlation between EUS-PPG and HVPG measurements in patients with portal hypertension due to cirrhosis?
- Can EUS-PPG serve as a reliable and less invasive alternative to HVPG for assessing portal pressure?
- What are the safety outcomes associated with EUS-PPG compared to HVPG?
Researchers will compare EUS-PPG measurements with HVPG measurements within the same patients to assess whether EUS-PPG provides accurate and clinically comparable portal pressure readings while reducing procedural risks.
Participants will:
- Be adults aged 18 to 85 with a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- Undergo both EUS-PPG and HVPG measurements within a seven-day window to allow for direct comparison of results.
- Receive standard clinical care for their condition, including routine diagnostic evaluations and portal hypertension management as needed.
- Be monitored for safety outcomes, including adverse events such as bleeding, infection, perforation, and any other complications related to the procedure.
- Provide relevant demographic and clinical data, including liver disease history, Child-Pugh and MELD scores, and portal hypertension-related complications such as varices or ascites.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-PPG and HVPG Measurement in Portal Hypertension | Experimental | Diagnostic Test: Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement, Diagnostic Test: Hepatic Venous Pressure Gradient (HVPG) Measurement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
- Subjects who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- Subjects capable of giving signed informed consent.
Key exclusion criteria (10 listed)
- Pregnancy.
- Significant bleeding risk (International Normalized Ratio (INR) > 1.5 OR platelet count < 50000).
- Presence of active gastrointestinal bleeding at the time of screening
- History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
- Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
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 |
|---|---|---|
| Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) MeasurementEndoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) measurement is a minimally invasive, ultrasound-based diagnostic procedure designed to assess portal hypertension in patients with chronic liver disease. Using an endoscopic ultrasound (EUS) probe, and a fine-needle aspiration (FNA) needle (EchoTip® Insight™) is used to directly measure intravascular pressures. Unlike the standard hepatic venous pressure gradient (HVPG) measurement, EUS-PPG provides direct pressure readings, does not require catheterization of the hepatic vein, and eliminates the need for radiation, iodinated contrast, and interventional radiology. This study aims to evaluate the accuracy, feasibility, and safety of EUS-PPG compared to HVPG. | Diagnostic test | EUS-PPG and HVPG Measurement in Portal Hypertension |
| Hepatic Venous Pressure Gradient (HVPG) MeasurementHepatic Venous Pressure Gradient (HVPG) measurement is the current gold standard for assessing portal hypertension in patients with chronic liver disease. The procedure involves catheterization of the hepatic vein via the jugular or femoral vein, where free hepatic venous pressure (FHVP) and wedged hepatic venous pressure (WHVP) are measured using a pressure transducer. HVPG is an indirect measure of portal pressure and requires fluoroscopy, radiation exposure, and specialized interventional radiology equipment. While widely used in clinical practice, HVPG has limitations, including the need for a hospital setting, potential patient discomfort, and limited feasibility in certain cases. This study will compare HVPG to EUS-PPG to determine whether EUS-PPG can serve as a less invasive and more accessible alternative. | Diagnostic test | EUS-PPG and HVPG Measurement in Portal Hypertension |
Primary outcome
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).
Time frame: 7 days
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) using the EchoTip® Insight™ needle and the hepatic venous pressure gradient (HVPG) measured through hepatic vein catheterization in patients with chronic portal hypertension due to liver cirrhosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement and Hepatic Venous Pressure Gradient (HVPG) Measurement in people with Portal Hypertension and Chronic Liver Disease (CLD), run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG). (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.