Measuring portal pressure in patients with advanced liver disease using endoscopic ultrasound
Evaluation of Direct Portal Pressure Measurement by Endoscopic Ultrasound in Advanced Chronic Liver Disease and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06266260 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with newly diagnosed esophago-gastric varices or those suspected of having clinically significant portal hypertension.
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.
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 performed: Other studies have shown promising results with similar endoscopic ultrasound techniques, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Roma
- 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
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.