Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Inflammation Clinical Trial

Official title:

Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03853447
• Other study ID #: H-18017281
• Status: Recruiting
• Start date: February 14, 2019
• Est. completion date: January 1, 2041

Study information

• Verified date: April 2020
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Srdan Novovic, PhD
• Phone: 38623862
• Email: srdan.novovic[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2041
• Est. primary completion date: January 1, 2040
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

Related Conditions & MeSH terms

• Acute Pancreatitis
• Chronic Pancreatitis
• Fibrosis
• Inflammation
• Pancreatitis
• Pancreatitis, Chronic
• Recurrent Pancreatitis

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Gastroenterology & Hepatology, Aalborg University Hospital	Aalborg
Denmark	Abdominal Centre, Bispebjerg University Hospital	Copenhagen
Denmark	Gastrounit, Copenhagen University Hospital Hvidovre	Hvidovre	Capital Region Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lean body mass assessed using bioimpedance	Body composition focusing on lean body mass will be assessed using bioimpedance	15 years