Fatty Liver and Pancreatic Steatosis

Not yet recruitingOBSERVATIONAL
Enrollment

61

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Exocrine Pancreatic InsufficiencyFatty Liver, NonalcoholicPancreatic Steatosis
Interventions
DIAGNOSTIC_TEST

Fecal elastase

\*\*Stool Samples\*\* To investigate exocrine pancreatic insufficiency (EPI), a stool sample will be requested from all patients for fecal elastase (Fel-1) analysis. Participants will be instructed to collect their stool sample in a sterile, disposable plastic container and submit it to the Gastroenterology Chemistry Laboratory (Litwin Laboratory) for processing and analysis. Based on previously published reports, samples will be stored refrigerated at 4-8 °C for no more than 48 hours. The concentrations of Fel-1 in all samples will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (ScheBo-Pancreatic Elastase 1™, Giessen, Germany), and fecal elastase will be extracted and analyzed according to the manufacturer's instructions.

DIAGNOSTIC_TEST

Ecoendoscopy

\*\*Diagnosis of Pancreatic Steatosis\*\* The diagnosis of pancreatic steatosis will be performed using endoscopic ultrasound. A Pentax EG-3870UTK endoscope will be used in conjunction with Hitachi Avius ultrasound equipment. The procedure is performed under anesthesia using propofol.

DIAGNOSTIC_TEST

Fibroscan

\*\*Fibroscan Procedure:\*\* This is a new technique based on the evaluation of liver elasticity or stiffness that allows for the measurement of liver hardness and quantification of liver fibrosis in a simple and completely painless manner using ultrasound. The results are obtained immediately and can be safely repeated periodically.

DIAGNOSTIC_TEST

Serum cytokines

Peripheral blood will be drawn from all participants in the Gastroenterology Division of the Hospital de Clínicas. Samples will be collected in EDTA tubes, centrifuged, and the serum will be frozen at -80 °C until processing. Serum cytokine levels will be measured using a commercial kit (Bio-Plex Pro human cytokine, Bio-Rad Lab., Inc.), which includes a panel of 27 cytokines: FGF basic, Eotaxin, G-CSF, GM-CSF, IFN-γ, IL-1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, MIP-1α, IL-12 (p70), MIP-1β, IL-13, PDGF-BB, IL-15, RANTES, IL-17, TNF-α, IP-10, VEGF, MCP-1 (MCAF).

Trial Locations (1)

1119

Hospital de Clinicas Jose de San Martin, Ciudad Autonoma de Buenos Aires

All Listed Sponsors
lead

Maria Marta Piskorz

OTHER

NCT06757348 - Fatty Liver and Pancreatic Steatosis | Biotech Hunter | Biotech Hunter