Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Characterization of Fibro-inflammation During 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.

Study Overview

• Status: Recruiting
• Conditions: Fibrosis; Inflammation; Pancreatitis; Chronic Pancreatitis; Acute Pancreatitis; Recurrent Pancreatitis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Srdan Novovic, PhD; Phone Number: 38623862; Email: srdan.novovic@regionh.dk
• Study Contact Backup: Name: Lise L Gluud, MSc; Phone Number: +45 38621964; Email: lise.lotte.gluud.01@regionh.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Department of Gastroenterology & Hepatology, Aalborg University Hospital
    • Contact: Soeren Schou Olesen, PhD; Phone Number: +45 97 66 00 00; Email: soso@dcm.aau.dk
  • Copenhagen, Denmark, 2200
    • Recruiting
    • Abdominal Centre, Bispebjerg University Hospital
    • Contact: Lars Nannestad Joergensen, PhD; Phone Number: +45 21 32 02 41; Email: lars.nannestad.joergensen@regionh.dk
  • Capital Region Denmark
    • Hvidovre, Capital Region Denmark, Denmark, 2650
      • Recruiting
      • Gastrounit, Copenhagen University Hospital Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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:

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: MRI and EUS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean body mass assessed using bioimpedance	Body composition focusing on lean body mass will be assessed using bioimpedance	15 years

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Anticipated): January 1, 2040
• Study Completion (Anticipated): January 1, 2041

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Inflammation; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: H-18017281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No