Clinical trial NCT05851534: Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
Official title: Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Pancreas Cancer
Surgery
Postoperative Complications
Keywords: Prehabilitation
Pancreas
Preoperative optimisation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Rising Tide Foundation
First posted: 2023-05-09
Enrollment: 2575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster randomized superiority trial
Primary purpose: PREVENTION

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?

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.

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)

Primary outcomes:
measure: Time to functional recovery
timeFrame: On average 6-10 days
Secondary outcomes:
measure: Comprehensive Complication Index (CCI)
timeFrame: 30 days postoperative
measure: Length of hospital stay
timeFrame: On average 2 weeks postoperative
measure: Readmissions
timeFrame: 30 days after discharge of primary admission
measure: Postoperative complications
timeFrame: During primary admission, on average 14 weeks postoperative
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 1 year postoperative
measure: Evaluation of health status
timeFrame: At baseline, 3 months and 12 months postoperative
measure: Evaluation of quality of life for cancer patients
timeFrame: At baseline, 3 months and 12 months postoperative
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Amsterdam
country: Netherlands
facility: OLVG
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maatricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: RAKU
Study officials:
affiliation: Maastricht University Medical Center/ University Maastricht
name: Marcel den Dulk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: