PReoperative Optimisation of Modifiable rIsk factorS in surgEry of the Pancreas:
the implementation of best practice before pancreatic resection

For pancreatic tumours, pancreatic resection is the cornerstone of curative
treatment. It is a major abdominal operation with up to 50% postoperative
morbidity. Patients with pancreatic and periampullary (pre)malignant tumours
(and sometimes pancreatitis) often suffer from severe weight loss and loss of
physical condition at the time of diagnosis, also known as (cancer) cachexia.

In studies, audits and the daily clinical practice, focus is on the treatment
itself, its complications and (long-term) outcome after treatment. Little
attention is given to the physical and mental condition of the patient at the
time of the diagnosis, before the treatment commences. However, e.g. reduced
preoperative aerobic fitness and preoperative anxiety have been associated with
worse postoperative outcome such as a higher chance for a postoperative
complication. Adequate preoperative screening to identify patient-related
modifiable risk factors associated with adverse outcomes and subsequently
influencing these risk factors in a multimodal, patient centred prehabilitation
program appears a promising intervention to improve outcomes of patients
undergoing pancreatic resection. Therefore, the hypothesis is that if the
patient's condition is optimised before major pancreatic surgery, the risk for
or impact of complications can be reduced resulting in an accelerated time to
recovery with an improved quality of life. Although promising,
unfortunately, strong evidence to support the contribution of prehabilitation
to optimize the functional outcome after surgery is still lacking.

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 compared to current practice.

A nationwide stepped-wedge cluster randomized superiority 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 trial, all centres
will have implemented the best practice program. The best practice program is
seen as standard care. In the current study, health related outcomes before and
after introduction of the program will be compared.

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 is considered the best practice care.

Prehabilitation in this study is considered standard care in the Netherlands
for pancreatic surgery. Various prehabilitation programs have been proven save
in different patient groups, like patients with colorectal cancer. Therefore,
the risks associated with this program are very low. All of the 8 preoperative
interventions are safe and already provided as standard care in some hospitals
in the Netherlands. It is important to standardize the preoperative
interventions in all hospitals to assess its effectiveness. The preoperative
program and additional questionnaire can impose a burden to the patient in
terms of time investment. Patients could benefit from the best practice
preoperative program, since our hypothesis is that patients have a shorter time
to functional recovery.