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

Not Applicable

• Conditions: Chronic pancreatitis; Digestive System; Other chronic pancreatitis

• Registration Number: ISRCTN13042622
• Lead Sponsor: Pancreatitis Werkgroep Nederland

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36611202/ (added 09/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-05
• Last Update Posted: 23 January 2023
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age =18 years
2. A diagnosis of CP according to the M-ANNHEIM criteria
3. Active treatment in one of the participating hospitals
4. Provided written informed consent (IC)

Exclusion Criteria

1. Women who are pregnant
2. End-stage diseases (<6 months estimated survival) due to cancer, chronic obstructive pulmonary disease and/or congestive heart failure
3. Suspected or established pancreatic malignancies
4. Uncompensated cirrhosis
5. Renal failure (GFR <25 ml/min or who are on dialysis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of life measured using PANQOLI-questionnaire and EQ5D questionnaire at baseline, start of intervention and 1 year after start of intervention<br>2. Pain measured using Izbicki questionnaire at baseline, start of intervention and 12 months after start of intervention

Secondary Outcome Measures

Name	Time	Method
1. Individual clinical outcomes measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention<br>2. Risk factors for disease progression measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention<br>3. Healthcare resource utilization measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention<br>4. Social participation measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention<br>5. Annual costs measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention