Trial Title:
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
NCT ID:
NCT05851534
Condition:
Prehabilitation
Pancreas Cancer
Surgery
Postoperative Complications
Conditions: Official terms:
Pancreatic Neoplasms
Postoperative Complications
Conditions: Keywords:
Prehabilitation
Pancreas
Preoperative optimisation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Stepped-wedge cluster randomized superiority trial
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Preoperative optimisation program
Description:
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
Arm group label:
Best practice program
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?
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam University Medical Center
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marc Besselink, MD PhD
Facility:
Name:
OLVG
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Tom Karsten, MD PhD
Facility:
Name:
Amphia Hospital
Address:
City:
Breda
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jennifer Schreinemakers, MD PhD
Facility:
Name:
Jeroen Bosch Hospital
Address:
City:
Den Bosch
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Koop Bosscha, MD PhD
Facility:
Name:
Catharina Hospital
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Ignace de Hingh, MD PhD
Facility:
Name:
Medisch Spectrum Twente
Address:
City:
Enschede
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Daan Lips, MD PhD
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Joost Klaase, MD PhD
Facility:
Name:
Medisch Centrum Leeuwarden
Address:
City:
Leeuwarden
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Eric Manusama, MD PhD
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Sven Mieog, MD PhD
Facility:
Name:
Maatricht University Medical Center
Address:
City:
Maastricht
Zip:
6202AZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marcel den Dulk, MD PhD
Facility:
Name:
Radboud University Medical Center
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Kees van Laarhoven, MD PhD
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Bas Groot Koerkamp, MD PhD
Facility:
Name:
RAKU
Address:
City:
Utrecht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Hjalmar van Santvoort, MD PhD
Start date:
September 2, 2024
Completion date:
September 2, 2028
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Rising Tide Foundation
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851534
