Postoperative Standardization of Care: the Implementation of Best Practice After Pancreatic Resection. A nationwide stepped-wedge cluster randomized trial.

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). Outcomes will be evaluated in all patients undergoing pancreatic resection in The Netherlands during the study period.



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, newonset organ failure and death). Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization, adjuvant chemotherapy and costs analysis. Follow-up will be 90 days after pancreatic resection

The hypothesis of this trial is that the 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.

Follow-up will be 90 days after pancreatic resection.

This trial evaluates a cluster level intervention in which clinicians involved in the postoperative care for patients undergoing pancreatic resection are informed on the best practice algorithm for early detection and minimally invasive management of postoperative pancreatic fistula.



To evaluate the effect of this intervention in terms of decreasing the risk of major complications and death, outcomes of patients undergoing pancreatic resection before implementation (i.e. current practice) will be compared to outcomes of patients undergoing pancreatic resection after implementation of the algorithm (i.e. best practice).