Status:
RECRUITING
Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Conditions:
Non-Alcoholic Fatty Liver Disease
Steatohepatitis, Nonalcoholic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent condition, and when fatty liver is associated with inflammation and hepatocellular injury (steatohepatitis), it can lead to fibrosis, ci...
Detailed Description
The estimated overall global prevalence of non-alcoholic fatty liver disease (NAFLD) is around 25% and projected at 33.5% in 2030. While simple steatosis without evidence of inflammation and hepatocel...
Eligibility Criteria
Inclusion
- clinical indication to perform a liver biospy for NAFLD assessment based on all of the following:
- presence of liver steatosi at ultrasound
- at least one risk factor for NASH/fibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome)
- increased liver enzymes (at least one of: GOT\>40 U/l, GPT\>49 U/l, GGT\>75 U/l) or high NAFLD fibrosis score (\>0.675), or intermediate NAFLD fibrosis score (between -1.455 and 0.675) and increased liver stiffness at transient elastography (\>7 KPa).
- consent to participate in the study
Exclusion
- age \< 18 years
- secondary causes of liver steatosis (moderate to severe alcohol consumption, steatogenic drugs)
- known diffuse liver diseases other than NAFLD (cirrhosis, viral or autoimmune hepatitis, hemochromatosis, amiloidosis, other) or previous primary or secondary liver neoplasms
- contraindications to perform liver biopsy (ascites, platelet count\<50.000/mmc, INR\>1.5, PT\>50%, serum bilirubin \>3 mg/dL)
- contraindications to perform magnetic resonance (pace-maker, claustrophobia, pregnancy, MR-unsafe metallic implants)
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04785937
Start Date
January 1 2019
End Date
December 31 2026
Last Update
June 25 2025
Active Locations (1)
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1
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy, 42123