Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Launched by AZIENDA USL REGGIO EMILIA - IRCCS · Mar 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how well different imaging tests, like ultrasound and MRI scans, can diagnose a liver condition called non-alcoholic steatohepatitis (NASH) and liver scarring (fibrosis) in people with non-alcoholic fatty liver disease (NAFLD). NAFLD happens when fat builds up in the liver, and if it leads to inflammation and damage (NASH), it can cause serious liver problems over time. Right now, the best way to check for these liver changes is with a liver biopsy, which involves taking a small tissue sample. However, biopsies can be uncomfortable and carry some risks, so this study wants to see if imaging tests can be a safe and accurate alternative.

People who may join the study are adults aged 65 to 74 who have fat in their liver seen on ultrasound, plus at least one risk factor like obesity, type 2 diabetes, or metabolic syndrome, along with abnormal liver blood tests or signs of liver stiffness. If you qualify, you will have both an ultrasound and a special MRI scan of your liver before having a biopsy. The researchers will compare the imaging results to the biopsy to see how well the scans can detect liver inflammation and scarring. This study is important because if imaging tests prove reliable, they could help doctors identify patients who need treatment without always needing a biopsy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * clinical indication to perform a liver biospy for NAFLD assessment based on all of the following:
• • 1. presence of liver steatosi at ultrasound
• • 2. at least one risk factor for NASH/fibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome)
• • 3. 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 Criteria:
• • 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)