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Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03853447
Enrollment
150
Registered
2019-02-25
Start date
2019-02-14
Completion date
2041-01-01
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis, Chronic Pancreatitis, Fibrosis, Inflammation, Pancreatitis, Recurrent Pancreatitis

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.

Interventions

DIAGNOSTIC_TESTDiagnostic imaging

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

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)15 yearsProgression of fibrosis in the pancreas based on either EUS or MRI

Secondary

MeasureTime frameDescription
Lean body mass assessed using bioimpedance15 yearsBody composition focusing on lean body mass will be assessed using bioimpedance

Countries

Denmark

Contacts

Primary ContactSrdan Novovic, PhD
srdan.novovic@regionh.dk38623862
Backup ContactLise L Gluud, MSc
lise.lotte.gluud.01@regionh.dk+45 38621964

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026