NCT06863012Recruiting
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 16 Apr 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Diseases
- High blood pressure
- NCT number
- NCT06863012
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 16 Apr 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
- Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.
Other illness
- 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 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.
Lab values
- Significant bleeding risk (International Normalized Ratio (INR) \> 1.5 OR platelet count \< 50000).
Other
- Pregnancy.
- Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
- Hepatocellular carcinoma not meeting Milan Criteria.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.