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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05851534
Other study ID # 2023-3607
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date May 15, 2028

Study information

Verified date May 2024
Source Maastricht University Medical Center
Contact Marcel den Dulk, MD PhD
Phone +3143 3875492
Email marcel.den.dulk@mumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2575
Est. completion date May 15, 2028
Est. primary completion date May 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
Netherlands Amsterdam University Medical Center Amsterdam
Netherlands OLVG Amsterdam
Netherlands Amphia Hospital Breda
Netherlands Jeroen Bosch Hospital Den Bosch
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

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Rising Tide Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
On average 6-10 days
Secondary Comprehensive Complication Index (CCI) The CCI is calculated as the sum of all complications that are weighted for their severity, with a range from 0 to 100, whereby a higher score indicates presence of more complications and/or more severe complications. 30 days postoperative
Secondary Length of hospital stay Length of hospital stay of the primary admission, measured in days On average 2 weeks postoperative
Secondary Readmissions Readmissions within 30 days after discharge 30 days after discharge of primary admission
Secondary Postoperative complications Any postoperative complication During primary admission, on average 14 weeks postoperative
Secondary Incremental cost-effectiveness ratio (ICER) The difference in costs between standard care and best practice care divided by the difference in health benefits, measured in quality-adjusted life years (QALYs). 1 year postoperative
Secondary Evaluation of health status Reported health status measured with questionnaire EQ-5D-5L At baseline, 3 months and 12 months postoperative
Secondary Evaluation of quality of life for cancer patients Reported quality of life measured with questionnaire EORTC QLQ-C30 At baseline, 3 months and 12 months postoperative
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