Clinical trial · Interventional
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
NCT03400280CI-TRIAL-00039071PORSCHunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Diseases | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best practice algorithm for postoperative care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Best practice
- description
- Postoperative care according to a best practice algorithm for postoperative care focussing on early detection and minimally invasive management of postoperative pancreatic fistula.
- interventionNames
- Other: Best practice algorithm for postoperative care
- type
- NO_INTERVENTION
- label
- Current practice
- description
- Postoperative care according to current usual practice.
Primary outcomes (1)
- measure
- Composite primary endpoint
- timeFrame
- 90 days after index pancreatic resection
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDSmits FJ, Molenaar IQ, Besselink MG, Busch OR, van Eijck CH, van Santvoort HC; Dutch Pancreatic Cancer Group. Management of postoperative pancreatic fistula after pancreatoduodenectomy: high mortality after completion pancreatectomy: Reply to: Bressan et al. completion pancreatectomy in the acute management of pancreatic fistula after pancreaticoduodenectomy. HPB (Oxford). 2018 Dec;20(12):1223. doi: 10.1016/j.hpb.2018.05.015. Epub 2018 Jun 22. No abstract available. PMID 29941289