Pancreatic DiseasesPORSCHNCT03400280
POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection
A study testing Best practice algorithm for postoperative care in people with Pancreatic Diseases and Pancreatic Neoplasms, run by St. Antonius Hospital at 17 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Diseases, Pancreatic Neoplasms, Pancreatic Cancer
- What is being tested?
- Best practice algorithm for postoperative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 17 sitesNetherlands
- Study dates
- 8 Jan 2018to 9 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All Dutch centers performing pancreatic surgery (i.e. performing at least 20 pancreatoduodenectomies a year)
- Patients underoging pancreatic resection for any indication
Who cannot join
- None
- None (i.e. complete enumeration)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Netherlands17 sites, 17 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Koop Bosscha
- Recruiting
Academic Medical Center
Amsterdam
Marc Besselink
- Recruiting
Onze Lieve Vrouwen Gasthuis
Amsterdam
Sebastiaan Festen
- Recruiting
VUmc
Amsterdam
Geert Kazemier
- Recruiting
Amphia ziekenhuis
Breda
Jennifer Schreinemakers
- Recruiting
Reinier de Graaf gasthuis
Delft
Daphne Roos
- Recruiting
Catharina ziekenhuis
Eindhoven
Ignace de Hingh
- Recruiting
Medisch Spectrum Twente
Enschede
Mike Liem
- Recruiting
UMCG
Groningen
Vincent de Meijer
- Recruiting
Tjongerschans
Heerenveen
Fennie Wit
- Recruiting
LUMC
Leiden
Bert Bonsing
- Recruiting
Maastricht UMC
Maastricht
Ronald van Dam
- Recruiting
Radboud UMC
Nijmegen
Marion van der Kolk
- Recruiting
Erasmus MC
Rotterdam
Casper van Eijck
- Recruiting
Maasstad ziekenhuis
Rotterdam
Erwin van der Harst
- Recruiting
RAKU (St. Antonius ziekenhuis & UMC Utrecht)
Utrecht
Hjalmar van Santvoort
Quintus Molenaar
- Recruiting
Isala klinieken
Zwolle
Gijs Patijn
About this study
Official title: POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection. a Nationwide Stepped-Wedge Cluster Randomized Trial
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.
Read the 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.
- Being tested
- Best practice algorithm for postoperative care
- Keywords
- Postoperative pancreatic fistula, Pancreatic resection
- Medical subject headings
- Pancreatic Diseases, Pancreatic Neoplasms, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practice algorithm for postoperative careOther
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Best practice | Experimental | Postoperative care according to a best practice algorithm for postoperative care focussing on early detection and minimally invasive management of postoperative pancreatic fistula. Receives: Other: Best practice algorithm for postoperative care |
| Current practice | No intervention | Postoperative care according to current usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days after index pancreatic resection
Secondary outcomes (7)
Postoperative mortality
Measured as rate of death at 90-day follow-up
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 90 days after index pancreatic resection
Adjuvant chemotherapy
Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up
Measured: 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.
Measured: 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.
Measured: 90 days after index pancreatic resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start8 Jan 2018
- Primary completion9 Nov 2019 (estimated)
- Study completion9 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, HC van Santvoort, St. Antonius Hospital
- Investigators
- Quintus Molenaar, MD, PhD, Principal investigator, UMC UtrechtHjalmar C van Santvoort, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400280
- Sponsor's protocol ID
- W17.057
- Other IDs
- UU2017-8272
- Acronym
- PORSCH
- Status last verified
- Jun 2019
- First submitted
- 21 Dec 2017
- Last updated
- 14 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
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.
PubMed 29941289
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection. a Nationwide Stepped-Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03400280
- Acronym / sponsor ID
- PORSCH / W17.057
- Keywords
- Postoperative pancreatic fistula, Pancreatic resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 9 Nov 2019 (estimated)
- Study completion
- 9 Feb 2020 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Best practice | Experimental | Other: Best practice algorithm for postoperative carePostoperative 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 intervention | –Postoperative care according to current usual practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All Dutch centers performing pancreatic surgery (i.e. performing at least 20 pancreatoduodenectomies a year)
- Patients underoging pancreatic resection for any indication
Key exclusion criteria (2 listed)
- None
- None (i.e. complete enumeration)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best practice algorithm for postoperative careSee arm/group description | Other | Best practice |
Primary outcome
Composite primary endpoint
Time frame: 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
7 secondary outcomes
Postoperative mortality
Time frame: 90 days after index pancreatic resection
New-onset organ failure
Time frame: 90 days after index pancreatic resection
Late postpancreatectomy bleeding
Time frame: 90 days after index pancreatic resection
Postoperative morbidity
Time frame: 90 days after index pancreatic resection
Adjuvant chemotherapy
Time frame: 90 days after index pancreatic resection
Success of implementation
Time frame: 90 days after index pancreatic resection
Cost-effectiveness
Time frame: 90 days after index pancreatic resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Derived from this study: PubMed 29941289Smits 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.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quintus Molenaar, MD, PhD principal investigator
UMC Utrecht
Hjalmar C van Santvoort, MD, PhD principal investigator
St. Antonius Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best practice algorithm for postoperative care in people with Pancreatic Diseases and Pancreatic Neoplasms, run by St. Antonius Hospital at 17 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasmijn Smits, MD (+31887571207, porsch@dpcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (time frame: 90 days after index pancreatic resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.