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Implementation study of an evidence-based management algorithm for patients with chronic pancreatitis

Implementation study of an evidence-based management algorithm for patients with chronic pancreatitis: a nationwide stepped-wedge cluster randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28232
Enrollment
120
Registered
2020-04-23
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pancreatitis

Interventions

Evidence-based management algorithm consisting of a combination of interventions, all considered as part of best practice, based on the recommendations of the United European Gastroenterology evidence

Sponsors

Erasmus MC, Department of Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Secondary

MeasureTime frame
1. Individual components of both co-primary outcomes 2. Process measure outcomes 3. Individual clinical outcomes 4. Participation at work 5. Healthcare resource utilization 6. Direct- and indirect costs

Primary

MeasureTime frame
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.

Contacts

Public ContactFleur de Rijk

Erasmus MC

f.de.rijk@antoniusziekenhuis.nl088 320 7050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)