Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorCopenhagen University Hospital, Hvidovre

About this trial

Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Diagnostic imaging

    Diagnostic test

    MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Diagnostic imaging1 intervention

Trial outcomes

Primary outcomes

1

Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)

Progression of fibrosis in the pancreas based on either EUS or MRI

Time frame
15 years

Secondary outcomes

1

Lean body mass assessed using bioimpedance

Body composition focusing on lean body mass will be assessed using bioimpedance

Time frame
15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.