Pancreatic Cancer, Pancreatic Diseases, Pancreatic Neoplasms, Pancreatitis
Conditions
Keywords
Postoperative pancreatic fistula, Pancreatic resection
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.
Interventions
OTHERBest practice algorithm for postoperative care
See arm/group description
Sponsors
Dutch Cancer Society
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stepped-wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite primary endpoint | 90 days after index pancreatic resection | The primary endpoint of this trial is a composite of the most severe complications associated to postoperative pancreatic fistula. This endpoint will be considered positive if one of the following complications occurs within 90 days after pancreatic resection: late postpancreatectomy bleeding, new-onset organ failure and/or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New-onset organ failure | 90 days after index pancreatic resection | Measured as organ failure occuring any time within 90 days after resection, not present at time of index pancreatic resection. |
| Late postpancreatectomy bleeding | 90 days after index pancreatic resection | Defined in accordance to the International Study Group on Pancreatic Surgery (ISGPS) definition as bleeding occurring any time after 24 hours after pancreatic resection. |
| Postoperative morbidity | 90 days after index pancreatic resection | Including complications according to the Clavien-Dindo system and pancreatectomy specific complications according to the ISGPS definitions (e.g. postpancreatectomy bleeding, postoperative pancreatic fistula, postoperative bile leak, postoperative chyle leak and delayed gastric emptying). |
| Postoperative mortality | 90 days after index pancreatic resection | Measured as rate of death at 90-day follow-up |
| Success of implementation | 90 days after index pancreatic resection | Measured as number of patients in whom the algorithm was not followed and timing of abdominal CT scans in both strategies. |
| Cost-effectiveness | 90 days after index pancreatic resection | Calculated by comparing health effects and medical costs related to both strategies up to 90 days after pancreatic resection. |
| Adjuvant chemotherapy | 90 days after index pancreatic resection | Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up |
Countries
Netherlands
Contacts
Primary ContactJasmijn Smits, MD
Backup ContactHjalmar C van Santvoort, MD, PhD
Outcome results
None listed