Fibro-inflammatory Progression From Acute to Chronic Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic imaging.
- Who it may be relevant to
- Registry conditions: Pancreatitis, Acute Pancreatitis, Recurrent Pancreatitis, Chronic Pancreatitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis
Overview
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.
Interventions
- Diagnostic test Diagnostic imaging
MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS
Primary outcome measures
- Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) [Time frame: 15 years]
Secondary outcome measures (1)
- Lean body mass assessed using bioimpedance [Time frame: 15 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Gastrounit, Copenhagen University Hospital Hvidovre — Hvidovre
- Department of Gastroenterology & Hepatology, Aalborg University Hospital — Aalborg
- Abdominal Centre, Bispebjerg University Hospital — Copenhagen
Identifiers
NCT: NCT03853447 · H-18017281