Clinical trial NCT03853447: Fibro-inflammatory Progression From Acute to Chronic Pancreatitis
Official title: Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatitis
Acute Pancreatitis
Recurrent Pancreatitis
Chronic Pancreatitis
Inflammation
Fibrosis
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CP, AC pr RAP who are not:

1. Pregnant or lactating patients
2. Contraindications to magnetic resonance imaging (MRI) or endoscopic ultrasound
3. Known chronic liver disease, chronic renal failure, malignancy, chronic inflammatory bowel syndrome, chronic obstructive lung disease, pulmonary fibrosis.
4. Treatment with anti-inflammatory drugs of any kind at the time of inclusion.

Brief 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.

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:

Primary outcomes:
measure: Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)
timeFrame: 15 years
Secondary outcomes:
measure: Lean body mass assessed using bioimpedance
timeFrame: 15 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Gastrounit, Copenhagen University Hospital Hvidovre
state: Capital Region Denmark
city: Aalborg
country: Denmark
facility: Department of Gastroenterology & Hepatology, Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Abdominal Centre, Bispebjerg University Hospital
Study officials:
References: