TY - JOUR

T1 - Characterisation of the fibroinflammatory process involved in progression from acute to chronic pancreatitis

T2 - Study protocol for a multicentre, prospective cohort study

AU - Novovic, Srdan

AU - Borch, Anders

AU - Werge, Mikkel

AU - Karran, David

AU - Gluud, Lise

AU - Schmidt, Palle Nordblad

AU - Hansen, Erik Feldager

AU - Nøjgaard, Camilla

AU - Jensen, Annette Bøjer

AU - Jensen, Frank Krieger

AU - Frøkjær, Jens Brøndum

AU - Hansen, Mark Berner

AU - Jørgensen, Lars Nannestad

AU - Drewes, Asbjørn Mohr

AU - Olesen, Søren Schou

PY - 2019

Y1 - 2019

N2 - Introduction Chronic pancreatitis (CP) is thought to present the end stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent AP, to early and end-stage CP. Due to the irreversible nature of CP, early detection and prevention is key. Prospective assessment based on advanced imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress may provide a better understanding of the underlying pathological processes and help identify novel biomarkers of disease with the ultimate goal of early diagnosis, intervention and prevention of disease progression. This paper describes the protocol of a prospective multicentre cohort study investigating the fibroinflammatory process involved in progression from acute to CP using state-of-the-art diagnostic imaging modalities and circulating biomarkers of inflammation, fibrosis and oxidative stress. Methods and analysis Adult control subjects and patients at different stages of CP according to the M-ANNHEIM system will be recruited from outpatient clinics at the participating sites and form three cohorts: controls (n=40), suspected CP (n=60) and definitive CP (n=60). Included patients will be followed prospectively for 15 years with advanced MRI and contrast-enhanced endoscopic ultrasound with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood samples for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential circulating biomarkers of disease progression, including markers of inflammation, fibrosis and oxidative stress. Ethics and dissemination Permissions from the Regional Science Ethics committee and the Regional Data Protection Agency have been obtained. We will submit the results of the study for publication in peer-reviewed journals regardless of whether the results are positive, negative or inconclusive.

AB - Introduction Chronic pancreatitis (CP) is thought to present the end stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent AP, to early and end-stage CP. Due to the irreversible nature of CP, early detection and prevention is key. Prospective assessment based on advanced imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress may provide a better understanding of the underlying pathological processes and help identify novel biomarkers of disease with the ultimate goal of early diagnosis, intervention and prevention of disease progression. This paper describes the protocol of a prospective multicentre cohort study investigating the fibroinflammatory process involved in progression from acute to CP using state-of-the-art diagnostic imaging modalities and circulating biomarkers of inflammation, fibrosis and oxidative stress. Methods and analysis Adult control subjects and patients at different stages of CP according to the M-ANNHEIM system will be recruited from outpatient clinics at the participating sites and form three cohorts: controls (n=40), suspected CP (n=60) and definitive CP (n=60). Included patients will be followed prospectively for 15 years with advanced MRI and contrast-enhanced endoscopic ultrasound with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood samples for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential circulating biomarkers of disease progression, including markers of inflammation, fibrosis and oxidative stress. Ethics and dissemination Permissions from the Regional Science Ethics committee and the Regional Data Protection Agency have been obtained. We will submit the results of the study for publication in peer-reviewed journals regardless of whether the results are positive, negative or inconclusive.

KW - chronic pancreatitis

KW - fibrosis

KW - inflammation

KW - oxidative stress

KW - pain processing

U2 - 10.1136/bmjopen-2019-028999

DO - 10.1136/bmjopen-2019-028999

M3 - Journal article

C2 - 31439604

AN - SCOPUS:85071247075

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 8

M1 - e028999

ER -