Measuring portal pressure in patients with advanced liver disease using endoscopic ultrasound
Official title: Evaluation of Direct Portal Pressure Measurement by Endoscopic Ultrasound in Advanced Chronic Liver Disease and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06266260 · Data updated 2026-11-12
This study is testing if a new way of measuring pressure in the liver using endoscopic ultrasound is better than the traditional method for people with advanced liver disease and high blood pressure in the portal vein.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | September 11, 2023 |
| Main results expected | April 1, 2025 |
| Study ends | April 1, 2026 |
| Registry record updated | March 14, 2025 |
| Trial ID | NCT06266260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with newly diagnosed esophago-gastric varices or those suspected of having clinically significant portal hypertension.
✕Probably not a fit
Patients with advanced liver disease classified as Child Pugh >A6, those with hepatocellular carcinoma, or portal vein thrombosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurements compared to traditional hepatic venous pressure gradient (HVPG) assessments in patients with advanced chronic liver disease and portal hypertension. The study will involve measuring portal pressure before and after treatment with non-selective beta blockers (NSBBs) to determine hemodynamic responses and identify factors influencing measurement accuracy. Additionally, the research will explore correlations between pressure measurements and the occurrence of liver-related complications, as well as changes in gut microbiota and elastography parameters. Follow-up visits will be conducted every 2-3 months to monitor patient outcomes.
Why it matters
Potential benefit: If successful, this study could improve the management of portal hypertension in patients with chronic liver disease by providing a safer and more accurate method for assessing portal pressure.
How similar studies have gone: Other studies have shown promising results with similar endoscopic ultrasound techniques, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests (porto- systemic collaterals at imaging, platelet count \<150.000 x mm3, spleen size \>13 cm in the largest axis, alteration of elastography parameters of the liver or spleen) * naïve to treatment with NSBBs, Exclusion Criteria: * Child Pugh \>A6 * Hepatocellular carcinoma * Portal vein thrombosis
Where it's running
-
Policlinico Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Francesco Santopaolo, MD — Fondazione Policlinico A. Gemelli IRCCS, Rome
- Study coordinator: Francesco Santopaolo, MD
- Email: francesco.santopaolo@policlinicogemelli.it
- Phone: +393492754288
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endohepatology-based reclassification of treatment indication in high-risk MASLD
This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.
-
Coil-assisted small-diameter stent shunt reduction for refractory HE after TIPS
A coil-assisted, small-diameter covered-stent technique is being tested to see if it can safely and effectively reduce shunt flow and lessen recurrent hepatic encephalopathy in people with a prior TIPS.
-
Austrian PBC Registry
This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.
-
4D-Flow MRI to see portal hypertension and TIPS outcomes in cirrhosis
This study tests a noninvasive 4D-Flow MRI method to see if it can safely and reliably reflect portal hypertension and predict outcomes for people with cirrhosis, including those needing a TIPS procedure.
-
Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis
This will test whether adding apixaban to carvedilol can help prevent variceal bleeding, portal vein thrombosis, and other portal-hypertension complications in adults with Child-Pugh B cirrhosis.
-
Blood clotting and portal vein changes during TIPS placement in cirrhosis
This project will see how blood clotting in the body and in the portal vein changes in adults with cirrhosis who are having a TIPS placed.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.