Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial

Trials, vol. 21, pp. 389

Abstract

BACKGROUND: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. METHODS: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains). The algorithm is designed to aid early detection and minimally invasive step-up management of postoperative pancreatic fistula. Outcomes of current practice will be compared with outcomes after implementation of the algorithm. The primary outcome is a composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death) and will be measured in a sample size of at least 1600 patients undergoing pancreatic resection. Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis. Follow up will be up to 90 days after pancreatic resection. DISCUSSION: It is hypothesized that a structured nationwide implementation of a dedicated algorithm for early detection and minimally invasive step-up management of postoperative pancreatic fistula will reduce the risk of major complications and death after pancreatic resection, as compared to current practice. TRIAL REGISTRATION: Netherlands Trial Register: NL 6671. Registered on 16 December 2017.

Authors 31

1. F. Jasmijn Smits

   University Medical Center Utrecht · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands

2. Anne Claire Henry

   Erasmus MC · University Medical Center Utrecht · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands

   Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

3. Casper H.J. van Eijck

   Erasmus MC · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

   Affiliation as printed

   Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

   Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

4. Marc G. Besselink

   Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

   Affiliation as printed

   Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

5. Olivier R. Busch

   Radboud University Medical Center · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

   Affiliation as printed

   Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

   Department of Radiology, Radboud University Medical Center, Nijmegen, The Netherlands

6. Mark J. Arntz

   Radboud University Medical Center · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Radiology, Radboud University Medical Center, Nijmegen, The Netherlands

   Department of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands

7. Thomas L. Bollen

   St. Antonius Ziekenhuis · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

   Affiliation as printed

   Department of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands

   Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

8. Otto M. van Delden

   St. Antonius Ziekenhuis · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

   Affiliation as printed

   Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

   Department of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands

9. Daniel van den Heuvel

   Maastricht University Medical Centre · Maastricht University · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands

   Department of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands

10. Christiaan van der Leij

    Maastricht University Medical Centre · Maastricht University · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

    Affiliation as printed

    Department of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands

    Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

11. Krijn P. van Lienden

    Erasmus MC · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam

    Affiliation as printed

    Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

    Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands

12. Adriaan D. Moelker Aachen Department of Surgery, Leiden University Medical Center

    Leiden University Medical Center · Erasmus MC

    Affiliation as printed

    Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands

    Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands

13. Bert A. Bonsing Aachen Department of Surgery, Leiden University Medical Center

    Leiden University Medical Center · University Medical Center Utrecht · St. Antonius Ziekenhuis

    Affiliation as printed

    Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands

    Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands

14. Inne H.M. Borel Rinkes

    University Medical Center Utrecht · St. Antonius Ziekenhuis · Jeroen Bosch Ziekenhuis

    Affiliation as printed

    Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands

    Department of Surgery, Jeroen Bosch Ziekenhuis, ´s-Hertogenbosch, The Netherlands

15. Koop P Bosscha

    Maastricht University Medical Centre · Maastricht University · Jeroen Bosch Ziekenhuis

    Affiliation as printed

    Department of Surgery, Jeroen Bosch Ziekenhuis, ´s-Hertogenbosch, The Netherlands

    Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands

16. Ronald M. van Dam

    Maastricht University Medical Centre · Maastricht University · OLVG

    Affiliation as printed

    Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands

    Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

17. Sebastiaan Festen

    Erasmus MC · OLVG

    Affiliation as printed

    Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

    Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

18. Bas Groot Koerkamp

    Erasmus MC · Maasstad Ziekenhuis

    Affiliation as printed

    Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

    Department of Surgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands

19. Erwin van der Harst

    Catharina Ziekenhuis · Maasstad Ziekenhuis

    Affiliation as printed

    Department of Surgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands

    Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands

20. Ignace H. J. T. de Hingh

    Catharina Ziekenhuis · Amsterdam University Medical Centers · Cancer Center Amsterdam

    Affiliation as printed

    Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands

    Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, VU University, Amsterdam, The Netherlands

21. Geert Kazemier

    Medisch Spectrum Twente · Amsterdam University Medical Centers · Cancer Center Amsterdam

    Affiliation as printed

    Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, VU University, Amsterdam, The Netherlands

    Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands

22. Mike S.L. Liem

    Medisch Spectrum Twente · Radboud University Medical Center

    Affiliation as printed

    Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands

    Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands

23. B.M. van der Kolk

    University Medical Center Groningen · University of Groningen · Radboud University Medical Center

    Affiliation as printed

    Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands

    Department of Surgery, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands

24. Vincent Erwin de Meijer

    University Medical Center Groningen · University of Groningen · Isala

    Affiliation as printed

    Department of Surgery, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands

    Department of Surgery, Isala Ziekenhuis, Zwolle, The Netherlands

25. Gijs A. Patijn

    Reinier de Graaf Hospital · Isala

    Affiliation as printed

    Department of Surgery, Isala Ziekenhuis, Zwolle, The Netherlands

    Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands

26. Daphne Roos

    Reinier de Graaf Hospital · Amphia Ziekenhuis

    Affiliation as printed

    Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands

    Department of Surgery, Amphia Ziekenhuis, Breda, The Netherlands

27. Jennifer MJ Schreinemakers

    Amphia Ziekenhuis · Tjongerschans

    Affiliation as printed

    Department of Surgery, Amphia Ziekenhuis, Breda, The Netherlands

    Department of Surgery, Tjongerschans, Heerenveen, The Netherlands

28. Fennie Wit

    Utrecht University · University Medical Center Utrecht · Tjongerschans

    Affiliation as printed

    Department of Surgery, Tjongerschans, Heerenveen, The Netherlands

    Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands

29. C. Henri van Werkhoven

    Utrecht University · University Medical Center Utrecht · St. Antonius Ziekenhuis

    Affiliation as printed

    Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands

    Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands

30. I. Quintus Molenaar

    University Medical Center Utrecht · St. Antonius Ziekenhuis

    Affiliation as printed

    Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands

31. Hjalmar C. van Santvoort corresponding

    University Medical Center Utrecht

    Affiliation as printed

    Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands. h.vansantvoort@umcutrecht.nl