Fibro-inflammatory Progression From Acute to Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT03853447|
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment|
|Pancreatitis Acute Pancreatitis Recurrent Pancreatitis Chronic Pancreatitis Inflammation Fibrosis||Diagnostic Test: Diagnostic imaging|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis|
|Actual Study Start Date :||February 14, 2019|
|Estimated Primary Completion Date :||January 1, 2040|
|Estimated Study Completion Date :||January 1, 2041|
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
MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS
Other Name: MRI and EUS
- Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) [ Time Frame: 15 years ]Progression of fibrosis in the pancreas based on either EUS or MRI
- Lean body mass assessed using bioimpedance [ Time Frame: 15 years ]Body composition focusing on lean body mass will be assessed using bioimpedance
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853447
|Contact: Srdan Novovic, PhDemail@example.com|
|Contact: Lise L Gluud, MSc||+45 firstname.lastname@example.org|
|Gastrounit, Copenhagen University Hospital Hvidovre||Recruiting|
|Hvidovre, Capital Region Denmark, Denmark, 2650|
|Contact: Lise L Gluud, MD +4538621964 email@example.com|
|Contact: Srdan Novovic, MD +38623862 firstname.lastname@example.org|
|Department of Gastroenterology & Hepatology, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Soeren Schou Olesen, PhD +45 97 66 00 00 email@example.com|
|Abdominal Centre, Bispebjerg University Hospital||Recruiting|
|Copenhagen, Denmark, 2200|
|Contact: Lars Nannestad Joergensen, PhD +45 21 32 02 41 firstname.lastname@example.org|