NCT05851534 Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
| NCT ID | NCT05851534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Prehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,575 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2027-09-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,575 participants in total. It began in 2024-09-02 with a primary completion date of 2027-09-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
Eligibility 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)
Contact & Investigator
Marcel den Dulk, MD PhD
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center/ University Maastricht
Frequently Asked Questions
Who can join the NCT05851534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05851534 currently recruiting?
Yes, NCT05851534 is actively recruiting participants. Contact the research team at marcel.den.dulk@mumc.nl for enrollment information.
Where is the NCT05851534 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands, Breda, Netherlands and 9 additional locations.
Who is sponsoring the NCT05851534 clinical trial?
NCT05851534 is sponsored by Maastricht University Medical Center. The principal investigator is Marcel den Dulk, MD PhD at Maastricht University Medical Center/ University Maastricht. The trial plans to enroll 2,575 participants.