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

Conditions

Chronic pancreatitis Digestive System Other chronic pancreatitis

de Rijk F, Thierens N, Veldhuisen CV, Aman BA, Anten M, Bhalla A, Bos PR, Brink MA, Curvers WL, Eijck BV, Geenen EV, Hadithi M, Inderson A, Kager LM, Keulemans YL, Koehestanie P, Kuiken SD, Poen AC, Quispel R, Römkens T, Sint Nicolaas J, van der Schaar PJ, Straathof J, Tan A, Thijs WJ, Tielemans MM, Venneman NG, Vleggaar FP, Voermans RP, Wanrooij RV, Verlaan T, Zoutendijk R, Besselink MG, Drenth J, Hooft JV, Santvoort HV, Werkhoven CV, Jonge P, Bruno MJ, Verdonk RC, Dutch Pancreatitis Study Group.

2026-03-17

10.14309/ajg.0000000000003995

Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial.

de Rijk FEM, van Veldhuisen CL, Besselink MG, van Hooft JE, van Santvoort HC, van Geenen EJM, van Werkhoven CH, de Jonge PJF, Bruno MJ, Verdonk RC, Dutch Pancreatitis Study Group.

2023-01-078 citations

10.1186/s13063-022-07044-8

Interventions

All participating hospitals cross over from current practice to care according to the treatment algorithm. The sequence of crossing over is randomized. Study participants will be enrolled during the c

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
1. Quality of life measured using PANQOLI-questionnaire and EQ5D questionnaire at baseline, start of intervention and 1 year after start of intervention 2. Pain measured using Izbicki questionnaire at baseline, start of intervention and 12 months after start of intervention	—

Secondary

Measure	Time frame
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 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 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 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 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	—

Measure

Time frame

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 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 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 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 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

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Countries

Netherlands

Outcome results

None listed