Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06888310

Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-21

408

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Non-alcoholic fatty liver disease (NAFLD) is responsible for a significant proportion of liver-related deaths and healthcare costs in the United States, accounting for approximately 36% of liver-related deaths and over one billion dollars in annual healthcare expenses. \[PMID: 34863359\] A recent analysis of healthcare costs in Italy showed that out of the 9,729 NAFLD/NASH patients who were hospitalized and analyzed, the vast majority (97%) did not have advanced liver disease, while 1.3% had compensated advanced liver disease (cACLD), 3.1% had decompensated cirrhosis, 0.8% had hepatocellular carcinoma, and 0.1% underwent liver transplantation. The burden of comorbidities was high across all patient cohorts, and patients with cACLD required a greater number of inpatient services, outpatient visits, and the pharmacy fills compared to those without advanced liver disease. As disease severity increased, mean total annual costs also increased primarily due to higher inpatient services costs. In Italy, as in other EU countries, most of the healthcare costs for patients were attributed to NAFLD/NASH-related liver complications. Thus, the optimization of the non-invasive diagnosis of cACLD represents an urgent need in dysmetabolic liver disease. These advancements will play a crucial role in early detection, risk stratification, and effective management of highly prevalent liver diseases such as NAFLD/NASH and their progression.

CONDITIONS

Official Title

Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Male or female sex
  • Diagnosis of dysmetabolic liver disease according to new definitions
  • Suspicion of compensated advanced chronic liver disease (cACLD) with liver stiffness measurement (LSM) of 10 or higher using vibration-controlled transient elastography (VCTE)
  • Routine esogastroduodenoscopy performed within 12 months of VCTE to identify high-risk varices (HRV)
Not Eligible

You will not qualify if you...

  • Presence of portal vein thrombosis
  • Presence of infiltrative liver tumors
  • Conditions affecting liver stiffness measurement such as congestive liver disease, extrahepatic biliary obstruction
  • Alanine aminotransferase (ALT) levels greater than 5 times the upper normal limit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Medicina Interna e Trapianto di Fegato

Roma, Italy, 00168

Actively Recruiting

Loading map...

Research Team

L

Luca Miele

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here