EUS-guided portal pressure measurement as an alternative to hepatic venous pressure
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
This trial will test whether an endoscopic ultrasound-guided portal pressure measurement (EUS-PPG) gives the same portal pressure readings as the standard HVPG in adults with portal hypertension from chronic liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fundacio Privada Mon Clinic Barcelona Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT06863012 on ClinicalTrials.gov |
What this trial studies
This investigator-initiated, single-arm prospective study performs both endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) and standard hepatic venous pressure gradient (HVPG) measurements in the same patients. Researchers will compare numeric pressure values to quantify correlation and agreement and will record procedure-related complications to compare safety. Eligible adults (18–85) with suspected or confirmed portal hypertension due to chronic liver disease will undergo both procedures at Hospital Clinic de Barcelona. The aim is to see if EUS-PPG provides clinically comparable portal pressure information while potentially reducing procedural risks and invasiveness.
Who should consider this trial
Good fit: Adults aged 18–85 with chronic liver disease and suspected or confirmed portal hypertension who can give informed consent and are scheduled for HVPG measurement are ideal candidates.
Not a fit: Patients with high bleeding risk, recent anticoagulant use, massive ascites, portal vein thrombosis, prior TIPS or surgical portosystemic shunt, pregnancy, or advanced hepatocellular carcinoma outside Milan criteria are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, EUS-PPG could provide a less invasive, potentially safer and more accessible way to measure portal pressure, reducing reliance on transjugular catheterization.
How similar studies have performed: Early single-center reports and small case series have shown promising correlation between EUS-PPG and HVPG, but larger prospective multicenter validation is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona, Barcelona
- Hospital Clinic de Barcelona — Barcelona, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.