Improving preoperative care for pancreatic surgery patients
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection
This study is testing a new health program to see if it helps patients get stronger and recover faster after pancreatic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2575 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 13 sites ('s-Hertogenbosch and 12 other locations) |
| Trial ID | NCT05851534 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a prehabilitation program designed to optimize the health of patients undergoing pancreatic surgery. It focuses on screening and addressing eight modifiable risk factors, including fitness level, nutrition, psychological resilience, and comorbidities. The study will utilize a stepped-wedge cluster randomized design across 13 centers in the Netherlands, transitioning from standard care to the best practice program in a randomized order. The primary outcomes include time to functional recovery and reduction in postoperative complications.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective pancreatic resection as part of curative treatment.
Not a fit: Patients under 18 years old or those requiring acute pancreatic resections will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance recovery times and reduce complications for patients undergoing pancreatic surgery.
How similar studies have performed: While previous studies have shown promise in prehabilitation for colorectal surgery, this approach for pancreatic surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * age \< 18 years * acute pancreatic resections (resection scheduled within two weeks)
Where this trial is running
's-Hertogenbosch and 12 other locations
- Jeroen Bosch Hospital — 's-Hertogenbosch, Netherlands (Recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Amphia Hospital — Breda, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Maatricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
- Raku — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marcel den Dulk, MD PhD — Maastricht University Medical Center/ University Maastricht
- Study coordinator: Marcel den Dulk, MD PhD
- Email: marcel.den.dulk@mumc.nl
- Phone: +3143 3875492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.