Using ultrasound to evaluate portal hypertension in liver cirrhosis patients
Role of Dynamic Contrast-enhanced Ultrasound (D-CEUS) and 2D Elastography in the Evaluation of Portal Hypertension and Risk of Oesophageal Variceal Bleeding in Patients With Liver Cirrhosis
This study is testing whether new ultrasound methods can help identify patients with liver cirrhosis who are at risk for portal hypertension without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05789641 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between non-invasive ultrasound techniques, specifically D-CEUS and elastography, and endoscopic parameters that predict clinically significant portal hypertension in patients with liver cirrhosis. The study will evaluate how well these ultrasound methods can identify patients at risk for portal hypertension compared to traditional invasive measurements. By analyzing liver stiffness and other ultrasound parameters, the researchers hope to establish cut-off values that can aid in risk stratification. The ultimate goal is to improve the management of portal hypertension in cirrhotic patients through non-invasive means.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with cirrhosis of various etiologies.
Not a fit: Patients with recent endoscopic treatment of oesophageal varices, portal thrombosis, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer, non-invasive method for assessing portal hypertension, reducing the need for invasive procedures.
How similar studies have performed: While the use of ultrasound elastography is gaining traction, this specific approach to evaluating portal hypertension is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * written informed consent * age more than 18 years * diagnosis of cirrhosis of different etiologies Exclusion criteria: * previous recent endoscopic treatment of oesophageal varices (\<6 months) * portal and/or splanchnic thrombosis * portal cavernomatosis * acute or chronic heart failure * previous liver transplantation * presence of hepatocellular carcinoma or other hepatic neoplasms * inadequate visualization of the liver parenchyma on B-mode ultrasound * known allergy to ultrasound contrast medium * pregnancy and lactation
Where this trial is running
Roma
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Assunta Zocco
- Email: mariaassunta.zocco@policlinicogemelli.it
- Phone: 00393470597805
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.