Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, Pancreatitis, Acute Pancreatitis, Recurrent Pancreatitis, Chronic Pancreatitis, Fibrosis

Intervention / Treatment
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* Diagnostic Test: Diagnostic imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CP (N=50) of any aetiology except gallstone induced CP: CP will be diagnosed based on MANNHEIM criteria . Cohort 2: Patients with their first attack of AP of any aetiology except gallstone induced AP (N=50). The revised Atlanta criteria for acute pancreatitis will be used as diagnostic criteria. Cohort 3: Patients with RAP (N=50) except gallstone induced RAP. RAP is defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic imaging<br>The progression of fibrosis will be assessed based on diagnostic imaging of thre subgroups including Patients with chronic pancreatitis (CP; N=50) of any aetiology, except gallstones, based on MANNHEIM. Patients with their first attack of acute pancreatitis (AP; N=50) of any aetiology except gallstones using the revised Atlanta criteria for AP. Patients with recurrent AP (RAP; N=50) except gallstones, defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria. | Diagnostic Test: Diagnostic imaging<br>* MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS<br>* Other names: MRI and EUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) | Progression of fibrosis in the pancreas based on either EUS or MRI | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass assessed using bioimpedance | Body composition focusing on lean body mass will be assessed using bioimpedance | 15 years |