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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic imaging | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic imaging | Diagnostic Test | MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lean body mass assessed using bioimpedance | Body composition focusing on lean body mass will be assessed using bioimpedance | 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CP, AC pr RAP who are not:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Srdan Novovic, PhD | Contact | 38623862 | srdan.novovic@regionh.dk | |
| Lise L Gluud, MSc | Contact | +45 38621964 | lise.lotte.gluud.01@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrounit, Copenhagen University Hospital Hvidovre | Recruiting | Hvidovre | Capital Region Denmark | 2650 | Denmark |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D050500 | Pancreatitis, Chronic |
| D007249 | Inflammation |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D008279 | Magnetic Resonance Imaging |
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D014463 | Ultrasonography |
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Plasma, serum and buffy coat
|
| Department of Gastroenterology & Hepatology, Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
|
| Abdominal Centre, Bispebjerg University Hospital | Recruiting | Copenhagen | 2200 | Denmark |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |