Actively Recruiting
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
Eligibility Criteria
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)
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
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
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
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