Clinical trial NCT03400280: POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection
Official title: POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection. a Nationwide Stepped-Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Diseases
Pancreatic Neoplasms
Pancreatic Cancer
Pancreatitis
Keywords: Postoperative pancreatic fistula
Pancreatic resection
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2018-01-17
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized trial
Primary purpose: TREATMENT

Brief summary: This Nationwide stepped-wedge cluster randomized trial is designed to evaluate if the implementation of a best practice algorithm for postoperative care results in a decrease in incidence of major complications and death after pancreatic resection as compared to current practice.

Detailed description: Rationale

Pancreatic resection is a major abdominal operation with 50% chance of postoperative complications. A feared complication is severe pancreatic fistula, in which there is leakage of enzyme rich fluid into the abdominal cavity. Adequate complication management appears to be the most important factor in improving outcomes of patients undergoing pancreatic resection.

Objective

To investigate whether implementation of a best practice algorithm for postoperative care focusing on early detection and step-up management of postoperative pancreatic fistula results in a lower rate of major complications and death after pancreatic resection as compared to current practice

Study design

A nationwide stepped-wedge, cluster randomized, superiority trial. In this design all participating centers cross over from current practice to best practice according to the algorithm, but are randomized to determine the exact order. At the end of the trial, all centers will have implemented the best practice algorithm.

Study population

All centers performing pancreatic surgery in the Netherlands (i.e. the Dutch Pancreatic Cancer Group).

Intervention

Cluster level education on postoperative care according to a best practice algorithm, focusing on early detection and step-up management of postoperative pancreatic fistula. This algorithm is based on findings in Dutch observational cohort studies, systematic literature analyses, an inventory in current protocols on postoperative care and expert opinion. The proposed algorithm is validated in a multicenter cohort and consensus upon this algorithm is reached with pancreatic surgeons from all centers of the Dutch Pancreatic Cancer Group. The final algorithm was reviewed critically by the advisory committee of internationally respected experts in the field of pancreatology before implementation in this trial.

Comparison

Postoperative care according to current practice.

Endpoints

The primary outcome was measured in all patients undergoing pancreatic resection and is a composite of major complications (i.e. postpancreatectomy bleeding, new-onset organ failure and death). Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, number of patients receiving adjuvant chemotherapy, healthcare resource utilization and costs analysis. Follow-up will be 90 days after pancreatic resection.

Eligibility criteria: Inclusion Criteria for Clusters:

* All Dutch centers performing pancreatic surgery (i.e. performing at least 20 pancreatoduodenectomies a year)

Exclusion Criteria for Clusters:

* None

Inclusion Criteria for Patients:

* Patients underoging pancreatic resection for any indication

Exclusion Criteria for Patients:

* None (i.e. complete enumeration)

Primary outcomes:
measure: Composite primary endpoint
timeFrame: 90 days after index pancreatic resection
Secondary outcomes:
measure: Postoperative mortality
timeFrame: 90 days after index pancreatic resection
measure: New-onset organ failure
timeFrame: 90 days after index pancreatic resection
measure: Late postpancreatectomy bleeding
timeFrame: 90 days after index pancreatic resection
measure: Postoperative morbidity
timeFrame: 90 days after index pancreatic resection
measure: Adjuvant chemotherapy
timeFrame: 90 days after index pancreatic resection
measure: Success of implementation
timeFrame: 90 days after index pancreatic resection
measure: Cost-effectiveness
timeFrame: 90 days after index pancreatic resection
Other outcomes:
Locations:
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
city: Amsterdam
country: Netherlands
facility: VUmc
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf gasthuis
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: UMCG
city: Heerenveen
country: Netherlands
facility: Tjongerschans
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
city: Utrecht
country: Netherlands
facility: RAKU (St. Antonius ziekenhuis & UMC Utrecht)
city: Zwolle
country: Netherlands
facility: Isala klinieken
Study officials:
affiliation: UMC Utrecht
name: Quintus Molenaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Hjalmar C van Santvoort, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smits FJ, Molenaar IQ, Besselink MG, Busch OR, van Eijck CH, van Santvoort HC; Dutch Pancreatic Cancer Group. Management of postoperative pancreatic fistula after pancreatoduodenectomy: high mortality after completion pancreatectomy: Reply to: Bressan et al. completion pancreatectomy in the acute management of pancreatic fistula after pancreaticoduodenectomy. HPB (Oxford). 2018 Dec;20(12):1223. doi: 10.1016/j.hpb.2018.05.015. Epub 2018 Jun 22. No abstract available.