EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional… (NCT06863012) | Clinical Trial Compass
RecruitingNot Applicable
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Spain20 participantsStarted 2025-04-16
Plain-language 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.
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:
* 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.
Exclusion Criteria:
* 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.
* 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.
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
1
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).