Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease

ConditionsNASHNAFLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • extra blood sampling

    Procedure/Surgery

    search for biomarkers for the prevention of liver disease

Treatment groups

408 Participants
are divided into 1 treatment group
Group A: patients with MASLD and LSM>=10kPaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

number of patients identified with single diagnostic method

evaluate the efficacy of risk-stratification pathways for cACLD detection and outcome prediction in adults (age\>18 years) with dysmetabolic liver disease in a tertiary care setting.

Time frame
24 months

Secondary outcomes

1

number of patients identified with innovative diagnostic method omic-based

evaluate the possible integration of liquid biopsy for cACLD detection and outcome prediction

Time frame
24 months

Other outcomes

Sponsors and contacts

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