PrehabilitationPROMISE-PNCT05851534
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
A study testing Preoperative optimisation program in people with Prehabilitation and Pancreas Cancer, run by Maastricht University Medical Center at 13 sites in Netherlands.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehabilitation, Pancreas Cancer, Surgery
- What is being tested?
- Preoperative optimisation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,575 participants
- Where
- 13 sitesNetherlands
- Study dates
- 2 Sep 2024to 2 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- age < 18 years
- acute pancreatic resections (resection scheduled within two weeks)
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Netherlands13 sites, 13 recruiting
- Recruiting
Jeroen Bosch Hospital
's-Hertogenbosch
Koop Bosscha, MD PhD
- Recruiting
Amsterdam University Medical Center
Amsterdam
Marc Besselink, MD PhD
- Recruiting
OLVG
Amsterdam
Tom Karsten, MD PhD
- Recruiting
Amphia Hospital
Breda
Jennifer Schreinemakers, MD PhD
- Recruiting
Catharina Hospital
Eindhoven
Ignace de Hingh, MD PhD
- Recruiting
Medisch Spectrum Twente
Enschede
Daan Lips, MD PhD
- Recruiting
University Medical Center Groningen
Groningen
Joost Klaase, MD PhD
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden
Eric Manusama, MD PhD
- Recruiting
Leiden University Medical Center
Leiden
Sven Mieog, MD PhD
- Recruiting
Maatricht University Medical Center
Maastricht, 6202AZ
Marcel den Dulk, MD PhD
- Recruiting
Radboud University Medical Center
Nijmegen
Kees van Laarhoven, MD PhD
- Recruiting
Erasmus Medical Center
Rotterdam
Bas Groot Koerkamp, MD PhD
- Recruiting
RAKU
Utrecht
Hjalmar van Santvoort, MD PhD
About this study
Official title: Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection
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:
- Does a prehabilitation program improve the time to functional recovery after pancreatic surgery?
- Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?
Read the detailed description
Background In the past, little attention has been given in the daily practice to the patient's condition before an operation. Recent studies have shown the benefit of preoperative optimisation programs. However, these studies consisted only of smaller studies and were mainly performed in patients who underwent colorectal surgery. Although promising, unfortunately, strong evidence to support the contribution of prehabilitation to optimize the functional outcome after surgery is still lacking and consequently it is not included in the Dutch basic health insurance package.
Objective To investigate whether implementation of a best practice program for preoperative optimisation of patients with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors (low (aerobic) fitness level, malnutrition, low psychological resilience, comorbidities (iron deficiency (anaemia), impaired glucose control and frailty), and intoxications (alcohol and smoking behaviour)) will improve the time to functional recovery.
Study design A nationwide stepped-wedge cluster randomized trial. In this design all participating centres will cross over from current practice to the best practice program, in a randomised order. At the end of the study, all centres will have implemented the best practice program.
Study population 13 centres performing major pancreatic surgery in the Netherlands collaborating within the Dutch Pancreatic Cancer Group (DPCG).
Intervention 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. This program is based on findings in previous screening and prehabilitation programs, a national inventory of current preoperative care protocols and expert opinion. Consensus upon this program was reached with pancreatic surgeons from all centres of the DPCG. The final program was critically reviewed by the advisory committee of internationally respected experts in the field of prehabilitation and pancreatology.
Comparison Preoperative care according to current practice.
- Conditions
- Prehabilitation, Pancreas Cancer, Surgery, Postoperative Complications
- Being tested
- Preoperative optimisation program
- Keywords
- Prehabilitation, Pancreas, Preoperative optimisation
- Medical subject headings
- Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative optimisation programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Receiving standard preoperative care |
| Best practice program | Experimental | Implementation of best practice preoperative optimisation program Receives: Behavioral: Preoperative optimisation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to functional recovery
Functional recovery is achieved when all of the following five criteria are met:
- 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.
Measured: On average 6-10 days
Secondary outcomes (7)
Comprehensive Complication Index (CCI)
The CCI is calculated as the sum of all complications that are weighted for their severity, with a range from 0 to 100, whereby a higher score indicates presence of more complications and/or more severe complications.
Measured: 30 days postoperative
Length of hospital stay
Length of hospital stay of the primary admission, measured in days
Measured: On average 2 weeks postoperative
Readmissions
Readmissions within 30 days after discharge
Measured: 30 days after discharge of primary admission
Postoperative complications
Any postoperative complication
Measured: During primary admission, on average 14 weeks postoperative
Incremental cost-effectiveness ratio (ICER)
The difference in costs between standard care and best practice care divided by the difference in health benefits, measured in quality-adjusted life years (QALYs).
Measured: 1 year postoperative
Evaluation of health status
Reported health status measured with questionnaire EQ-5D-5L
Measured: At baseline, 3 months and 12 months postoperative
Evaluation of quality of life for cancer patients
Reported quality of life measured with questionnaire EORTC QLQ-C30
Measured: At baseline, 3 months and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start2 Sep 2024
- Primary completion2 Sep 2027 (estimated)
- Study completion2 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge cluster randomized superiority trial
- Masking
- None (open label)
- Enrolment
- 2,575 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rising Tide Foundation
- Responsible party
- Sponsor
- Investigators
- Marcel den Dulk, MD PhD, Principal investigator, Maastricht University Medical Center/ University Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851534
- Sponsor's protocol ID
- 2023-3607
- Acronym
- PROMISE-P
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be shared, after deidentification upon reasonable request.