An interventional study of Best practice algorithm for postoperative care in Pancreatic Diseases, Pancreatic Neoplasms and Pancreatic Cancer, sponsored by St. Antonius Hospital. Status unknown at 17 sites in Netherlands. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by St. Antonius Hospital · Not applicable, Interventional, and Treatment
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Among 10 studies in Pancreatic Diseases with a site in Netherlands — 1 open to participants now, 1 under way, none of them phase 3. Pancreatic Diseases · Netherlands.
Among the 10 studies in Pancreatic Diseases with a site in Netherlands, this one is the only one that started in 2018, is one of 2 with no phase, and was the 6th registered.
184 studies on the registry are indexed under Pancreatic Diseases; 63 are open to participants now.
Browse Pancreatic Diseases studies →1 of the 10 studies in Pancreatic Diseases with a site in Netherlands is open now. Recruiting first, the newest first:
UMC Utrecht · Sites in Netherlands
Healthy volunteers
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 43 Pancreatic Diseases studies recruiting now, 25 (58%) set no upper age limit and 4 (9%) stop at 75 or younger; 7 take children under 18; 8 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3
First in 2009; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,600 is above the median of 96 across 104 interventional studies indexed under Pancreatic Diseases.
Median enrollment 256 across the 7 interventional studies, 1,672 across the 3 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
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3 of 10 have an industry lead sponsor. The 9 most frequent:
St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.
St. Antonius Hospital has 1 study filed under Pancreatic Diseases — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Pancreatic Diseases with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Inclusion Criteria for Clusters:
Exclusion Criteria for Clusters:
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
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
Postoperative care according to current usual practice.
See arm/group description
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
Time frame: 90 days after index pancreatic resection
Postoperative mortality
Measured as rate of death at 90-day follow-up
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 90 days after index pancreatic resection
Adjuvant chemotherapy
Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up
Time frame: 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.
Time frame: 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.
Time frame: 90 days after index pancreatic resection
Plan to share: 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)
Supporting information: Study protocol
Time frame: Upon request
Access criteria: Upon request
Started Jan 2018 (actual). Primary completion is estimated for Nov 2019, 22 months after the start.
Of 32 interventional studies with no phase under Pancreatic Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 44. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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St. Antonius Hospital