Validation of an Ultrasound Score for Fatty Pancreas

Prospective Observational Study for the Validation of an Ultrasound Scoring System for the Assessment of Fatty Pancreas

This prospective observational study aims to validate an ultrasound scoring system for the assessment of fatty pancreas by comparing it with the current reference standard, magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF). The study will also investigate clinical and laboratory parameters associated with fatty pancreas as potential biomarkers of disease severity and evaluate the relationship between pancreatic fat accumulation, glucose tolerance and pancreatic β-cell function.

Study Overview

• Status: Completed
• Conditions: Fatty Pancreas

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll adult male and female patients aged 18-65 years who are referred to the Pancreatic Diseases Unit with a hyperechoic pancreas on abdominal ultrasound.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To validate an ultrasound scoring system for the assessment of fatty pancreas by comparing it with the current gold standard, magnetic resonance imaging-based pancreatic fat quantification using proton density fat fraction (MRI-PDFF).	The diagnostic performance of the ultrasound score will be evaluated by assessing its agreement with MRI-PDFF measurements and its ability to accurately identify and grade pancreatic fat infiltration.	12 months
To identify clinical and laboratory parameters currently used in the diagnosis and follow-up of pancreatic disease that may serve as biomarkers of disease severity.	Clinical characteristics, biochemical markers, and pancreatic function parameters will be analyzed to identify variables associated with the severity of fatty pancreas and to explore their potential role as non-invasive biomarkers.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the association between the degree of fatty pancreas and glucose tolerance status, as well as β-cell function.	The relationship between pancreatic fat accumulation and abnormalities in glucose metabolism will be investigated by assessing glucose tolerance and pancreatic β-cell function, with the aim of determining whether increasing pancreatic fat content is associated with impaired endocrine function and an increased risk of dysglycemia	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Antonio Gasbarrini, Fondazione Policlinico Universitario Agostino Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 3507

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No