Plain English Summary
Background and study aims
Chronic pancreatitis is a condition where the pancreas has become permanently damaged from inflammation and stops working properly. The pancreas is a small organ, located behind the stomach, that helps with digestion. Chronic pancreatitis can affect people of any age, but it usually develops between the ages of 30 and 40 as a result of heavy drinking over many years. It's more common in men.
Chronic pancreatitis is associated with a markedly reduced life expectancy and quality of life. In a recently performed study, current care for patients with chronic pancreatitis in the Netherlands proved not to be in accordance with the in 2017 published European guideline.
The aim of the present study is to assess whether standardized care through the implementation of an evidence-based management 'algorithm' of interventions for patients with chronic pancreatitis results in an improvement in quality of life and reduction of pain severity as compared to current practice.
Who can participate?
Chronic pancreatitis patients who meet the in- and exclusion criteria and are receiving active treatment in one of the participating centers of the Dutch Pancreatitis Study Group.
What does the study involve?
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 current practice phase and be followed until the end of the study. In the end, this evidence-based management algorithm will be implemented in all participating hospitals. The evidence-based management algorithm consists of a combination of interventions, based on the recommendation of the United European Gastroenterology evidence-based guidelines will be compared with care according to current practice.
What are the possible benefits and risks of participating?
There are no additional/potential risks for participating in this trial. Possible benefits: During the intervention phase all participating patients will be treated according to our standardized evidence-based management algorithm.
Where is the study run from?
Dutch Pancreatitis Study Group, St. Antonius Hospital (The Netherlands)
When is the study starting and how long is it expected to run for?
July 2020 to July 2023
Who is funding the study?
Mylan (The Netherlands)
Who is the main contact?
Prof. dr. M. Bruno, m.bruno@erasmusmc.nl
Dr. F.E.M. de Rijk , f.de.rijk@antoniusziekenhuis.nl
Trial website
Contact information
Type
Scientific
Primary contact
Miss Florence de Rijk
ORCID ID
Contact details
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
+31 (0)88 3207050
f.de.rijk@antoniusziekenhuis.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
NL8556
Study information
Scientific title
Implementation study of an evidence-based management algorithm for patients with chronic pancreatitis: a nationwide stepped-wedge cluster randomized controlled trial (COMBO trial)
Acronym
COMBO
Study hypothesis
The aim of this study is to investigate whether the implementation of an evidence-based management algorithm consisting of a combination of interventions for the management of chronic pancreatitis (CP) results in an improvement of patient outcomes.
Ethics approval
On 21/04/2020 the MEC-U (Medical Research Ethics Committees United; Postbus 2500, 3430 EM Nieuwegein, Koekoekslaan 1, Netherlands; +31 (0)88 3208784; info@mec-u.nl) ruled that this study is not subject to the Medical Research Involving Human Subjects Act (WMO), ref: W20.074
Study design
Nationwide stepped-wedge cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Stepped-wedge cluster randomized controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
https://combo-studie.nl/ (in Dutch)
Condition
Chronic pancreatitis
Intervention
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 current practice phase and be followed longitudinally until the end of the study. In the end, this evidence-based management algorithm will be implemented in all participating hospitals.
The evidence-based management algorithm consists of a combination of interventions, all considered as part of best practice, based on the recommendations of the United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (2017) and extensive systematic literature analysis. The interventions included in this algorithm are particularly focused on education of both physicians and patients, management of risk factors for disease progression and regular screening for and treatment of complications of chronic pancreatitis. The final algorithm has been critically reviewed by the advisory committee of international experts in the field of chronic pancreatitis before implementation in this trial.
Follow up will be 18 months after the start of the intervention.
Intervention type
Other
Phase
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
02/07/2020
Overall trial end date
31/07/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 CP patients with a time since diagnosis ≤3 years
Participant 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)
Recruitment start date
07/09/2020
Recruitment end date
31/12/2021
Locations
Countries of recruitment
Netherlands
Trial participating centre
Amsterdam UMC, locatie AMC
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Trial participating centre
Amsterdam AMC, locatie VUMC
De Boelelaan 1117, 1118
Amsterdam
1081 HV
Netherlands
Trial participating centre
Amphia Ziekenhuis
Langendijk 75
Breda
4819 EV
Netherlands
Trial participating centre
St. Antonius Ziekenhuis
3435 CM
Netherlands
Trial participating centre
Bravis Ziekenhuis
4708 AE
Netherlands
Trial participating centre
Catharina Ziekenhuis
5623 EJ
Netherlands
Trial participating centre
Canisius Wilhelmina Ziekenhuis
6532 SZ
Netherlands
Trial participating centre
Erasmus MC
3015 GD
Netherlands
Trial participating centre
Sint Franciscus Gasthuis
3045 PM
Netherlands
Trial participating centre
Haga Ziekenhuis
2545 AA
Netherlands
Trial participating centre
Isala Ziekenhuis
8025 AB
Netherlands
Trial participating centre
Jeroen Bosch Ziekenhuis
5223 GZ
Netherlands
Trial participating centre
Leids Universitair Medisch Centrum
2333 ZA
Netherlands
Trial participating centre
Maasstad Ziekenhuis
3079 DZ
Netherlands
Trial participating centre
Martini Ziekenhuis
9728 NT
Netherlands
Trial participating centre
Meander MC
3813 TZ
Netherlands
Trial participating centre
Maxima MC
5631 BM
Netherlands
Trial participating centre
Medisch Spectrum Twente
7512 KZ
Netherlands
Trial participating centre
Noordwest Ziekenhuisgroep
1815 JD
Netherlands
Trial participating centre
OLVG
1091 AC
Netherlands
Trial participating centre
Radboud UMC
6525 GA
Netherlands
Trial participating centre
Reinier de Graaf Gasthuis
2625 AD
Netherlands
Trial participating centre
Spaarne Gasthuis
2134 TM
Netherlands
Trial participating centre
UMC Utrecht
3584 CX
Netherlands
Trial participating centre
Ziekenhuis Gelderse Vallei
6716 RP
Netherlands
Trial participating centre
Zuyderland MC
6162 BG
Netherlands
Sponsor information
Organisation
Pancreatitis Werkgroep Nederland
Sponsor details
St. Antonius Ziekenhuis
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
+31 (0)88 320 30000
info@pancreatitis.nl
Sponsor type
Research organisation
Website
Organisation
Erasmus University Medical Center
Sponsor details
Department of Gastroenterology
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 7040704
f.derijk@erasmusmc.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Mylan Healthcare B.V.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. The researchers would like to publish their study protocol in the future, so for now this protocol is not available online for non-participating centers.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/07/2024
Participant level data
Other
Basic results (scientific)
Publication list