Validation of an Ultrasound Score for Fatty Pancreas

Fatty pancreas is an increasingly recognized condition associated with obesity and metabolic dysfunction. Although magnetic resonance imaging with proton density fat fraction (MRI-PDFF) is currently considered the reference standard for non-invasive quantification of pancreatic fat, its limited availability and high cost restrict its routine clinical use. Conventional abdominal ultrasonography is widely available, inexpensive, and easily repeatable, but standardized and validated methods for the assessment of pancreatic steatosis are lacking.The primary objective of this prospective observational study is to validate an ultrasound scoring system for the assessment of fatty pancreas by comparing ultrasound findings with pancreatic fat quantification obtained by MRI-PDFF. In addition, the study aims to identify clinical and laboratory parameters associated with pancreatic steatosis that may serve as non-invasive biomarkers of disease severity and facilitate disease monitoring.The secondary objective is to evaluate the association between the degree of fatty pancreas and glucose metabolism, including glucose tolerance status and pancreatic β-cell function, in order to better characterize the metabolic consequences of pancreatic fat accumulation.

Inclusion criteria

• Male or female patients aged 18 to 65 years.
• Diagnosis of fatty pancreas confirmed by magnetic resonance imaging (MRI).
• Adequate pancreatic visualization on abdominal ultrasound, defined as visualization of at least 50% of the pancreatic parenchyma.
• Provision of written informed consent, signed and dated prior to study enrollment.
• Ability to understand the nature of the study and to comply with all study procedures and protocol requirements.

Exclusion criteria

• Age <18 years or >65 years.
• Any psychiatric condition, cognitive impairment, or other circumstance that, in the investigator's judgment, may compromise the participant's ability to comply with the study procedures or protocol requirements.
• Patients with a diagnosis of chronic pancreatitis, pancreatic neoplasms, congenital pancreatic disorders, viral infections, iron overload disorders, or a history of medication use or other medical conditions that may increase pancreatic echogenicity, thereby acting as potential confounding factors in the interpretation of the ultrasound findings.