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RecruitingNASHNAFLD

Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease

Eligible age

18+ yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

No

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About this study

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.

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

You may qualify if…

  • 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).

You may not qualify if…

  • 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).

Source: ClinicalTrials.gov · NCT06888310 · last updated 2025-03-21

Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced · TrialPath