Implementation study of an evidence-based management algorithm for patients with chronic pancreatitis
- Conditions
- Chronic pancreatitis
- Registration Number
- NL-OMON28232
- Lead Sponsor
- Erasmus MC, Department of Gastroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
An age = 18 years
-A diagnosis of CP according to the M-ANNHEIM criteria
-Active treatment in one of the participating hospitals
-Provided written informed consent (IC)
Exclusion Criteria
-Pregnancy
-End-stage diseases (< 6 months estimated survival) due to cancer, chronic obstructive pulmonary disease and/or congestive heart failure
-Suspected or established pancreatic malignancies
-Uncompensated cirrhosis
-Renal failure (GFR < 25 ml/min or who are on dialysis)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method There are two co-primary outcomes: quality of life assessed with a pancreatitis quality of life questionnaire and pain severity assessed with the Izbicki-pain score. Both will be measured longitudinally in all included patients.
- Secondary Outcome Measures
Name Time Method 1. Individual components of both co-primary outcomes<br>2. Process measure outcomes<br>3. Individual clinical outcomes <br>4. Participation at work<br>5. Healthcare resource utilization <br>6. Direct- and indirect costs