POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection
NCT ID: NCT03400280
Last Updated: 2019-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1600 participants
INTERVENTIONAL
2018-01-08
2020-02-09
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Best practice
Postoperative care according to a best practice algorithm for postoperative care focussing on early detection and minimally invasive management of postoperative pancreatic fistula.
Best practice algorithm for postoperative care
See arm/group description
Current practice
Postoperative care according to current usual practice.
No interventions assigned to this group
Interventions
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Best practice algorithm for postoperative care
See arm/group description
Eligibility Criteria
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Inclusion Criteria
* Patients underoging pancreatic resection for any indication
Exclusion Criteria
* None (i.e. complete enumeration)
ALL
Yes
Sponsors
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Dutch Cancer Society
OTHER
St. Antonius Hospital
OTHER
Responsible Party
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HC van Santvoort
Principal Investigator
Principal Investigators
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Quintus Molenaar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Hjalmar C van Santvoort, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Academic Medical Center
Amsterdam, , Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, , Netherlands
VUmc
Amsterdam, , Netherlands
Amphia ziekenhuis
Breda, , Netherlands
Reinier de Graaf gasthuis
Delft, , Netherlands
Catharina ziekenhuis
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
UMCG
Groningen, , Netherlands
Tjongerschans
Heerenveen, , Netherlands
LUMC
Leiden, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Maasstad ziekenhuis
Rotterdam, , Netherlands
RAKU (St. Antonius ziekenhuis & UMC Utrecht)
Utrecht, , Netherlands
Isala klinieken
Zwolle, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Koop Bosscha
Role: primary
Marc Besselink
Role: primary
Sebastiaan Festen
Role: primary
Geert Kazemier
Role: primary
Jennifer Schreinemakers
Role: primary
Daphne Roos
Role: primary
Ignace de Hingh
Role: primary
Mike Liem
Role: primary
Vincent de Meijer
Role: primary
Fennie Wit
Role: primary
Bert Bonsing
Role: primary
Ronald van Dam
Role: primary
Marion van der Kolk
Role: primary
Casper van Eijck
Role: primary
Erwin van der Harst
Role: primary
Hjalmar van Santvoort
Role: primary
Quintus Molenaar
Role: backup
Gijs Patijn
Role: primary
References
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Smits 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.
Other Identifiers
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UU2017-8272
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
W17.057
Identifier Type: -
Identifier Source: org_study_id
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