Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
PROMISE-P
1 other identifier
interventional
2,575
1 country
13
Brief Summary
The goal of this stepped-wedge randomized controlled trial is to investigate whether implementation of a best practice program for preoperative optimisation (prehabilitation program) with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors in patients with (suspected) pancreatic cancer will improve outcome. The main questions it will aim to answer are:
- 1.Does a prehabilitation program improve the time to functional recovery after pancreatic surgery?
- 2.Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
September 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 2, 2028
October 26, 2024
October 1, 2024
3 years
April 14, 2023
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to functional recovery
Functional recovery is achieved when all of the following five criteria are met: a) restored level of mobility at the preoperative level, b) sufficient pain control with oral medication alone, c) ability to maintain at least 50% daily required energy intake, d) no intravenous fluid administration, and e) no clinical signs of infection.
On average 6-10 days
Secondary Outcomes (7)
Comprehensive Complication Index (CCI)
30 days postoperative
Length of hospital stay
On average 2 weeks postoperative
Readmissions
30 days after discharge of primary admission
Postoperative complications
During primary admission, on average 14 weeks postoperative
Incremental cost-effectiveness ratio (ICER)
1 year postoperative
- +2 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONReceiving standard preoperative care
Best practice program
EXPERIMENTALImplementation of best practice preoperative optimisation program
Interventions
Preoperative screening of all patients scheduled for pancreatic resection on (aerobic) fitness level, malnutrition risk, psychological resilience, haemoglobin, iron and HbA1c concentration, frailty, and alcohol and smoking behaviour. All patients are provided with a patient-tailored, multimodal prehabilitation program, in which these potentially (partly) modifiable factors are preoperatively addressed
Eligibility Criteria
You may qualify if:
- All patients who are planned for a curative treatment with or without neoadjuvant treatment and elective pancreatic resection in one of the centres of the Dutch Pancreatic Cancer Group (i.e. all centres performing major pancreatic surgery)
You may not qualify if:
- age \< 18 years
- acute pancreatic resections (resection scheduled within two weeks)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Rising Tide Foundationcollaborator
Study Sites (13)
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maatricht University Medical Center
Maastricht, 6202AZ, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
RAKU
Utrecht, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel den Dulk, MD PhD
Maastricht University Medical Center/ University Maastricht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 9, 2023
Study Start
September 2, 2024
Primary Completion (Estimated)
September 2, 2027
Study Completion (Estimated)
September 2, 2028
Last Updated
October 26, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 5 years following article publication
- Access Criteria
- Data will be available upon request. Request should be directed to marcel.den.dulk@mumc.nl.
All of the individual participant data collected during the trial will be shared, after deidentification upon reasonable request.