Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Surgery Clinical Trial

— PROMISE-P  

Official title:

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05851534
• Other study ID #: 2023-3607
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms
• Postoperative Complications
• Prehabilitation
• Surgery

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