EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Recruiting · NCT06863012 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundacio Privada Mon Clinic Barcelona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Hospital Clinic de Barcelona - Barcelona, Barcelona, Spain