Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Recruiting

• Conditions: Chronic Pancreatitis; Inflammation; Pancreatitis; Acute Pancreatitis; Recurrent Pancreatitis; Fibrosis
• Interventions: Diagnostic Test: Diagnostic imaging

• Registration Number: NCT03853447
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08
• Primary Completion: 2040-01-01
• Study Completion: 2041-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic imaging	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.

Primary Outcome Measures

Name	Time	Method
Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)	15 years	Progression of fibrosis in the pancreas based on either EUS or MRI

Secondary Outcome Measures

Name	Time	Method
Lean body mass assessed using bioimpedance	15 years	Body composition focusing on lean body mass will be assessed using bioimpedance

Trial Locations

Locations (3)

Gastrounit, Copenhagen University Hospital Hvidovre; 🇩🇰 Hvidovre, Capital Region Denmark, Denmark

Abdominal Centre, Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Gastroenterology & Hepatology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark