ClinicalTrials.gg
RecruitingNCT06863012EUS-PPGUpdated Sep 11, 2026

EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG

An interventional study of Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement and Hepatic Venous Pressure Gradient (HVPG) Measurement in Portal Hypertension, Chronic Liver Disease (CLD) and Cirrhosis, sponsored by Fundacio Privada Mon Clinic Barcelona. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Fundacio Privada Mon Clinic Barcelona · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • 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
03

In context

Hypertension, Portal

375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 231 interventional studies indexed under Hypertension, Portal.

Browse Hypertension, Portal studies →

Lead sponsor

Fundacio Privada Mon Clinic Barcelona is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must be 18 to 85 years of age inclusive, at the time of signing the 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • Significant bleeding risk ( (INR) > 1.5 OR 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.
  • 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 or affecting study participation.
  • Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    EUS-PPG and HVPG Measurement in Portal Hypertension

    Diagnostic Test: Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement · Diagnostic Test: Hepatic Venous Pressure Gradient (HVPG) Measurement

Interventions

  • Diagnostic testEndoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement

    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.

  • Diagnostic testHepatic Venous Pressure Gradient (HVPG) Measurement

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.

Of 57 non-industry interventional studies with no phase under Hypertension, Portal, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 72. This study's planned 20 months is below that.

Counting every sponsor, half of 61 studies reached it within 41 months; a quarter within 19 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2025
First posted
Mar 7, 2025
StartActual
Apr 16, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06863012
Lead sponsor
Fundacio Privada Mon Clinic Barcelona
Responsible party
Sponsor
First posted
Mar 7, 2025
Start date
Apr 16, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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