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NCT Number: NCT03853447

Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastrounit, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region Denmark, Denmark

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic imaging

Diagnostic Test

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

Other names: MRI and EUS

Primary outcomes

  1. 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

Secondary outcomes

  1. Lean body mass assessed using bioimpedance

    Time frame: 15 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise L Gluud, MSc

CONTACT

[email protected]

+45 38621964

Srdan Novovic, PhD

CONTACT

[email protected]

38623862

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2040
Study completion
2041
First posted
Feb 25, 2019
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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