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Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Sponsor: Maastricht University Medical Center • ClinicalTrials.gov ID: NCT05851534

Registry updated: 2026-10-19

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Description

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?

Interventions

Preoperative optimisation program (Behavioral)
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

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)

Conditions

Prehabilitation Pancreas Cancer Surgery Postoperative Complications

Locations

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, Netherlands
Radboud University Medical Center — Nijmegen, Netherlands
Erasmus Medical Center — Rotterdam, Netherlands
RAKU — Utrecht, Netherlands

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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