Validation of an Ultrasound Score for Fatty Pancreas

NCT07722689 | Completed

• 1 other identifier: 3507
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatty Pancreas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To evaluate the association between the degree of fatty pancreas and glucose tolerance status, as well as β-cell function.

  12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Study Officials

• Antonio Gasbarrini

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: October 1, 2020
• Primary Completion: June 23, 2022
• Study Completion: December 1, 2023
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

IT (1)