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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Diseases, Pancreatic Neoplasms, Pancreatic Cancer, Pancreatitis

Intervention / Treatment
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* Other: Best practice algorithm for postoperative care


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped-wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Best practice<br>Postoperative care according to a best practice algorithm for postoperative care focussing on early detection and minimally invasive management of postoperative pancreatic fistula. | Other: Best practice algorithm for postoperative care<br>* See arm/group description<br>|
| No Intervention: Current practice<br>Postoperative care according to current usual practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary endpoint | 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 | 90 days after index pancreatic resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative mortality | Measured as rate of death at 90-day follow-up | 90 days after index pancreatic resection | 
| New-onset organ failure | Measured as organ failure occuring any time within 90 days after resection, not present at time of index pancreatic resection. | 90 days after index pancreatic resection | 
| Late postpancreatectomy bleeding | Defined in accordance to the International Study Group on Pancreatic Surgery (ISGPS) definition as bleeding occurring any time after 24 hours after pancreatic resection. | 90 days after index pancreatic resection | 
| Postoperative morbidity | 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). | 90 days after index pancreatic resection | 
| Adjuvant chemotherapy | Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up | 90 days after index pancreatic resection | 
| Success of implementation | Measured as number of patients in whom the algorithm was not followed and timing of abdominal CT scans in both strategies. | 90 days after index pancreatic resection | 
| Cost-effectiveness | Calculated by comparing health effects and medical costs related to both strategies up to 90 days after pancreatic resection. | 90 days after index pancreatic resection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pancreatic fistula, Pancreatic resection