POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection
PORSCH
2 other identifiers
interventional
1,600
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2017
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2020
CompletedJune 14, 2019
June 1, 2019
1.8 years
December 21, 2017
June 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Postoperative mortality
90 days after index pancreatic resection
New-onset organ failure
90 days after index pancreatic resection
Late postpancreatectomy bleeding
90 days after index pancreatic resection
Postoperative morbidity
90 days after index pancreatic resection
Adjuvant chemotherapy
90 days after index pancreatic resection
- +2 more secondary outcomes
Study Arms (2)
Best practice
EXPERIMENTALPostoperative care according to a best practice algorithm for postoperative care focussing on early detection and minimally invasive management of postoperative pancreatic fistula.
Current practice
NO INTERVENTIONPostoperative care according to current usual practice.
Interventions
Eligibility Criteria
You may qualify if:
- All Dutch centers performing pancreatic surgery (i.e. performing at least 20 pancreatoduodenectomies a year)
You may not qualify if:
- None
- Patients underoging pancreatic resection for any indication
- None (i.e. complete enumeration)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Antonius Hospitallead
- Dutch Cancer Societycollaborator
Study Sites (17)
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
Related Publications (1)
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.
PMID: 29941289DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Quintus Molenaar, MD, PhD
UMC Utrecht
- PRINCIPAL INVESTIGATOR
Hjalmar C van Santvoort, MD, PhD
St. Antonius Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2017
First Posted
January 17, 2018
Study Start
January 8, 2018
Primary Completion
November 9, 2019
Study Completion
February 9, 2020
Last Updated
June 14, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Upon request
- Access Criteria
- Upon request
The datasets generated during and/or analysed during the current study are/will be available upon request from Hjalmar van Santvoort (h.van.santvoort@antoniusziekenhuis.nl)