Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Behavioral: Preoperative optimisation program. 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 public domain (ClinicalTrials.gov)

Standard care (no intervention): Receiving standard preoperative care

Arm public domain (ClinicalTrials.gov)

Best practice program (experimental): Implementation of best practice preoperative optimisation program

Primary outcome public domain (ClinicalTrials.gov)

Time to functional recovery. Functional recovery is achieved when all of the following five criteria are met: a) restored level of mobility at the preoperative level, b) sufficient pain control with oral medication alone, c) ability to maintain at least 50% daily required energy intake, d) no intravenous fluid administration, and e) no clinical signs of infection. Time frame: On average 6-10 days.

Secondary outcome public domain (ClinicalTrials.gov)

Comprehensive Complication Index (CCI). Time frame: 30 days postoperative.

Secondary outcome public domain (ClinicalTrials.gov)

Length of hospital stay. Time frame: On average 2 weeks postoperative.

Secondary outcome public domain (ClinicalTrials.gov)

Readmissions. Time frame: 30 days after discharge of primary admission.

Secondary outcome public domain (ClinicalTrials.gov)

Postoperative complications. Time frame: During primary admission, on average 14 weeks postoperative.

Secondary outcome public domain (ClinicalTrials.gov)

Incremental cost-effectiveness ratio (ICER). Time frame: 1 year postoperative.

Secondary outcome public domain (ClinicalTrials.gov)

Evaluation of health status. Time frame: At baseline, 3 months and 12 months postoperative.

Eligibility public domain (ClinicalTrials.gov)

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)

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 2575 participants (estimated).