NCT06863012 EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
| NCT ID | NCT06863012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacio Privada Mon Clinic Barcelona |
| Condition | Portal Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-04-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06863012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Portal Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06863012 currently recruiting?
Yes, NCT06863012 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fundacio Privada Mon Clinic Barcelona to inquire about joining.
Where is the NCT06863012 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06863012 clinical trial?
NCT06863012 is sponsored by Fundacio Privada Mon Clinic Barcelona. The trial plans to enroll 20 participants.