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Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT03853447
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Lise Gluud, Copenhagen University Hospital, Hvidovre

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.

Condition or disease Intervention/treatment
Pancreatitis Acute Pancreatitis Recurrent Pancreatitis Chronic Pancreatitis Inflammation Fibrosis Diagnostic Test: Diagnostic imaging

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : January 1, 2040
Estimated Study Completion Date : January 1, 2041

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diagnostic imaging

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.

Diagnostic Test: Diagnostic imaging
MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS
Other Name: MRI and EUS




Primary Outcome Measures :
  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 Outcome Measures :
  1. Lean body mass assessed using bioimpedance [ Time Frame: 15 years ]
    Body composition focusing on lean body mass will be assessed using bioimpedance


Biospecimen Retention:   Samples With DNA
Plasma, serum and buffy coat


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853447


Contacts
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Contact: Srdan Novovic, PhD 38623862 srdan.novovic@regionh.dk
Contact: Lise L Gluud, MSc +45 38621964 lise.lotte.gluud.01@regionh.dk

Locations
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Denmark
Gastrounit, Copenhagen University Hospital Hvidovre Recruiting
Hvidovre, Capital Region Denmark, Denmark, 2650
Contact: Lise L Gluud, MD    +4538621964    lise.lotte.gluud.01@regionh.dk   
Contact: Srdan Novovic, MD    +38623862    srdan.novovic@regionh.dk   
Department of Gastroenterology & Hepatology, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Soeren Schou Olesen, PhD    +45 97 66 00 00    soso@dcm.aau.dk   
Abdominal Centre, Bispebjerg University Hospital Recruiting
Copenhagen, Denmark, 2200
Contact: Lars Nannestad Joergensen, PhD    +45 21 32 02 41    lars.nannestad.joergensen@regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre

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Responsible Party: Lise Gluud, Associate Professor, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT03853447     History of Changes
Other Study ID Numbers: H-18017281
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Inflammation
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases