POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection
POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection
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.
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.
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)