Status:
RECRUITING
Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
NASH
NAFLD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-relat...
Detailed Description
The study aims to significantly enhance diagnostic innovation and contribute to the existing literature on the stratification of cACLD caused by metabolic-dysfunction liver disease, a major factor lea...
Eligibility Criteria
Inclusion
- age\>=18; sex (M,F);
- dysmetabolic liver disease according new nomenclature definition;
- suspicion of cACLD by LSM\>=10 with VCTE;
- routine esogastroduodenoscopy report within 12 months of VCTE for identification of high-risk varices (HRV).
Exclusion
- portal vein thrombosis,
- infiltrative liver neoplasms, and conditions are known for their potential influence on the LSM results (congestive liver disease, extrahepatic biliary obstruction, ALT \> 5x upper normal limit).
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT06888310
Start Date
December 6 2024
End Date
March 1 2027
Last Update
March 21 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Medicina Interna e Trapianto di Fegato
Roma, Italy, 00168