Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

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Brief Title

Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Official Title

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


Study Type

Observational


Primary Outcome

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

Secondary Outcome

 Lean body mass assessed using bioimpedance

Condition

Pancreatitis

Intervention

Diagnostic imaging

Study Arms / Comparison Groups

 Diagnostic imaging
Description:  The progression of fibrosis will be assessed based on diagnostic imaging of thre subgroups including
Patients with chronic pancreatitis (CP; N=50) of any aetiology, except gallstones, based on MANNHEIM.
Patients with their first attack of acute pancreatitis (AP; N=50) of any aetiology except gallstones using the revised Atlanta criteria for AP.
Patients with recurrent AP (RAP; N=50) except gallstones, defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

150

Start Date

February 14, 2019

Completion Date

January 1, 2041

Primary Completion Date

January 1, 2040

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:
      

Gender

All

Ages

18 Years - 70 Years


Contacts

, 38623862, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03853447

Organization ID

H-18017281


Responsible Party

Principal Investigator

Study Sponsor

Copenhagen University Hospital, Hvidovre


Study Sponsor

, , 


Verification Date

April 2020