NCT03853447

Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Copenhagen University Hospital, Hvidovre · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress.

Detailed description

Chronic pancreatitis (CP) represents the end-stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent acute pancreatitis (RAP). Due to the irreversible nature of CP, early detection and prevention is key. The study uses state-of-the-art imaging modalities as well as biochemical markers of to evaluate fibrosis progression in patients with pancreatitis. The included participants have either first time AP, RAP, early CP with preserved pancreatic exocrine and endocrine function or end-stage CP with exocrine insufficiency. Included patients will be followed prospectively for 15 years with advanced MRI and contrast enhanced EUS with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential biomarkers for the progression of disease eventually leading to CP.

Conditions

• Pancreatitis
• Acute Pancreatitis
• Recurrent Pancreatitis
• Chronic Pancreatitis
• Inflammation
• Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic imaging	MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS

Timeline

• Start date: 2019-02-14
• Primary completion: 2040-01-01
• Completion: 2041-01-01
• First posted: 2019-02-25
• Last updated: 2020-04-08

Locations

3 sites across 1 country: Denmark