Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

NCT03853447 | Recruiting

• 1 other identifier: H-18017281
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatitis; Acute Pancreatitis; Recurrent Pancreatitis; Chronic Pancreatitis; Inflammation; Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lean body mass assessed using bioimpedance

  15 years

Study Arms (1)

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

Interventions

Diagnostic imaging DIAGNOSTIC_TEST

MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS

Also known as: MRI and EUS

Diagnostic imaging

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (3)

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region Denmark, 2650, Denmark

RECRUITING

Department of Gastroenterology & Hepatology, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Abdominal Centre, Bispebjerg University Hospital

Copenhagen, 2200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and buffy coat

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic; Inflammation; Fibrosis

Interventions

Diagnostic Imaging; Magnetic Resonance Imaging; Endosonography

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Tomography; Ultrasonography

Central Study Contacts

Srdan Novovic, PhD

CONTACT

38623862; srdan.novovic@regionh.dk

Lise L Gluud, MSc

CONTACT

+45 38621964; lise.lotte.gluud.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 25, 2019
• Study Start: February 14, 2019
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2041
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)