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

ISRCTN ISRCTN13042622
DOI https://doi.org/10.1186/ISRCTN13042622
Secondary identifying numbers NL8556
Submission date
01/09/2020
Registration date
05/09/2020
Last edited
09/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 inclusion 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

Study website

Contact information

Miss Florence de Rijk
Scientific

Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Phone +31 (0)88 3207050
Email f.de.rijk@antoniusziekenhuis.nl

Study information

Study designNationwide stepped-wedge cluster randomized controlled trial
Primary study designInterventional
Secondary study designStepped-wedge cluster randomized controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet https://combo-studie.nl/ (in Dutch)
Scientific titleImplementation study of an evidence-based management algorithm for patients with chronic pancreatitis: a nationwide stepped-wedge cluster randomized controlled trial (COMBO trial)
Study acronymCOMBO
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedChronic pancreatitis
InterventionAll 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date02/07/2020
Completion date31/07/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120 CP patients with a time since diagnosis ≤3 years
Key inclusion criteria1. 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)
Key exclusion criteria1. 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)
Date of first enrolment07/09/2020
Date of final enrolment31/12/2022

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Amsterdam UMC, locatie AMC
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Amsterdam AMC, locatie VUMC
De Boelelaan 1117, 1118
Amsterdam
1081 HV
Netherlands
Amphia Ziekenhuis
Langendijk 75
Breda
4819 EV
Netherlands
St. Antonius Ziekenhuis
3435 CM
Netherlands
Bravis Ziekenhuis
4708 AE
Netherlands
Catharina Ziekenhuis
5623 EJ
Netherlands
Canisius Wilhelmina Ziekenhuis
6532 SZ
Netherlands
Erasmus MC
3015 GD
Netherlands
Sint Franciscus Gasthuis
3045 PM
Netherlands
Haga Ziekenhuis
2545 AA
Netherlands
Isala Ziekenhuis
8025 AB
Netherlands
Jeroen Bosch Ziekenhuis
5223 GZ
Netherlands
Leids Universitair Medisch Centrum
2333 ZA
Netherlands
Maasstad Ziekenhuis
3079 DZ
Netherlands
Martini Ziekenhuis
9728 NT
Netherlands
Meander MC
3813 TZ
Netherlands
Maxima MC
5631 BM
Netherlands
Medisch Spectrum Twente
7512 KZ
Netherlands
Noordwest Ziekenhuisgroep
1815 JD
Netherlands
OLVG
1091 AC
Netherlands
Radboud UMC
6525 GA
Netherlands
Reinier de Graaf Gasthuis
2625 AD
Netherlands
Spaarne Gasthuis
2134 TM
Netherlands
UMC Utrecht
3584 CX
Netherlands
Ziekenhuis Gelderse Vallei
6716 RP
Netherlands
Zuyderland MC
6162 BG
Netherlands

Sponsor information

Pancreatitis Werkgroep Nederland
Research organisation

St. Antonius Ziekenhuis
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Phone +31 (0)88 320 30000
Email info@pancreatitis.nl
Website https://www.pancreatitis.nl/
ROR logo "ROR" https://ror.org/007r3zy44
Erasmus University Medical Center
Research organisation

Department of Gastroenterology
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Phone +31 (0)10 7040704
Email f.derijk@erasmusmc.nl
Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Industry

Mylan Healthcare B.V.

No information available

Results and Publications

Intention to publish date31/07/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned 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 planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 07/01/2023 09/01/2023 Yes No

Editorial Notes

09/01/2023: Publication reference added.
04/10/2022: The recruitment end date was changed from 30/09/2022 to 31/12/2022.
08/03/2022: The recruitment end date was changed from 31/03/2022 to 30/09/2022.
01/06/2021: The recruitment end date was changed from 31/12/2021 to 31/03/2022.
03/09/2020: Trial’s existence confirmed by Medical Research Ethics Committees United.