NCT03400280

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

POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection. a Nationwide Stepped-Wedge Cluster Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pancreatic Diseases
• Pancreatic Neoplasms
• Pancreatic Cancer
• Pancreatitis

Interventions

Type	Name	Description
OTHER	Best practice algorithm for postoperative care	See arm/group description

Timeline

• Start date: 2018-01-08
• Primary completion: 2019-11-09
• Completion: 2020-02-09
• First posted: 2018-01-17
• Last updated: 2019-06-14

Locations

17 sites across 1 country: Netherlands