Actively Recruiting
Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis
Led by Copenhagen University Hospital, Hvidovre · Updated on 2020-04-08
150
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the progression from acute pancreatitis (AP) and recurrent acute pancreatitis (RAP) to chronic pancreatitis (CP), focusing on the development of fibrosis and inflammation. The study aims to better understand how these conditions evolve over time using advanced imaging and biochemical markers. Participants include those with first-time AP, RAP, early CP with preserved pancreatic function, or end-stage CP with exocrine insufficiency. Participants are divided into three groups: those with CP, first-time AP, and RAP, excluding cases caused by gallstones. The study uses advanced magnetic resonance imaging (MRI) techniques and endoscopic ultrasound (EUS) with elastography to assess fibrosis progression. In addition, assessments of pancreatic function, biochemical and nutritional status, and pain processing are conducted. Blood samples will be collected for biobank storage to analyze potential biomarkers related to disease progression. Over 15 years, participants will undergo regular MRI and EUS imaging, pancreatic function tests, nutritional assessments, and pain evaluations. The main focus is on measuring fibrosis progression through imaging. Researchers will also monitor body composition using bioimpedance. The study involves long-term follow-up to capture changes over time and aims to provide insights into chronic pancreatitis development and progression.
CONDITIONS
Brief Title
Fibro-inflammatory Progression From Acute to Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with chronic pancreatitis (CP) of any cause except gallstones, based on MANNHEIM criteria
- Patients with a first attack of acute pancreatitis (AP) of any cause except gallstones, diagnosed by revised Atlanta criteria
- Patients with recurrent acute pancreatitis (RAP), defined as two or more AP episodes, excluding gallstone causes
- Adults aged 18 to 70 years
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 years
Participants undergo advanced MRI and contrast enhanced endoscopic ultrasound (EUS) with elastography, biochemical and nutritional assessments, and evaluation of pancreatic function and pain processing.
Regular imaging and assessments over 15 years
Duration - 15 years
Participants are followed prospectively to monitor fibrosis progression and other clinical outcomes related to pancreatitis over an extended period.
Ongoing assessments throughout the study period
Trial Site Locations
Total: 3 locations
1
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Denmark, Denmark, 2650
Actively Recruiting
2
Department of Gastroenterology & Hepatology, Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
3
Abdominal Centre, Bispebjerg University Hospital
Copenhagen, Denmark, 2200
Actively Recruiting
Research Team
S
Srdan Novovic, PhD
L
Lise L Gluud, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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