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.

Details

Title
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
Author
Smits, F. Jasmijn 1   VIAFID ORCID Logo  ; Henry, Anne Claire 1 ; van Eijck, Casper H. 2 ; Besselink, Marc G. 3 ; Busch, Olivier R. 3 ; Arntz, Mark 4 ; Bollen, Thomas L. 5 ; van Delden, Otto M. 6 ; van den Heuvel, Daniel 7 ; van der Leij, Christiaan 8 ; van Lienden, Krijn P. 6 ; Moelker, Adriaan 9 ; Bonsing, Bert A. 10 ; Borel Rinkes, Inne H. M. 1 ; Bosscha, Koop 11 ; van Dam, R. M. 12 ; Festen, Sebastiaan 13 ; Groot Koerkamp, B. 2 ; van der Harst, Erwin 14 ; de Hingh, Ignace H. 15 ; Kazemier, Geert 16 ; Liem, Mike 17 ; van der Kolk, B. Marion 18 ; de Meijer, Vincent E. 19 ; Patijn, Gijs A. 20 ; Roos, Daphne 21 ; Schreinemakers, Jennifer M. 22 ; Wit, Fennie 23 ; van Werkhoven, C. Henri 24 ; Molenaar, I. Quintus 1 ; van Santvoort, Hjalmar C. 1 

1  St. Antonius Hospital and University Medical Center Utrecht, Department of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, The Netherlands (GRID:grid.7692.a) (ISNI:0000000090126352) 
2  Erasmus Medical Center, Department of Surgery, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X) 
3  University of Amsterdam, Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands (GRID:grid.7177.6) (ISNI:0000000084992262) 
4  Radboud University Medical Center, Department of Radiology, Nijmegen, The Netherlands (GRID:grid.10417.33) (ISNI:0000 0004 0444 9382) 
5  St. Antoniusziekenhuis, Department of Radiology, Nieuwegein, The Netherlands (GRID:grid.10417.33) 
6  University of Amsterdam, Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands (GRID:grid.7177.6) (ISNI:0000000084992262) 
7  St. Antoniusziekenhuis, Department of Radiology, Nieuwegein, The Netherlands (GRID:grid.7177.6) 
8  Maastricht University Medical Center, Department of Radiology, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382) 
9  Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X) 
10  Leiden University Medical Center, Department of Surgery, Leiden, The Netherlands (GRID:grid.10419.3d) (ISNI:0000000089452978) 
11  Jeroen Bosch Ziekenhuis, Department of Surgery, ´s-Hertogenbosch, The Netherlands (GRID:grid.413508.b) (ISNI:0000 0004 0501 9798) 
12  Maastricht University Medical Center, Department of Surgery, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382) 
13  Onze Lieve Vrouwe Gasthuis, Department of Surgery, Amsterdam, The Netherlands (GRID:grid.440209.b) 
14  Maasstad Ziekenhuis, Department of Surgery, Rotterdam, The Netherlands (GRID:grid.416213.3) (ISNI:0000 0004 0460 0556) 
15  Catharina Ziekenhuis, Department of Surgery, Eindhoven, The Netherlands (GRID:grid.413532.2) (ISNI:0000 0004 0398 8384) 
16  VU University, Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands (GRID:grid.12380.38) (ISNI:0000 0004 1754 9227) 
17  Medisch Spectrum Twente, Department of Surgery, Enschede, The Netherlands (GRID:grid.415214.7) (ISNI:0000 0004 0399 8347) 
18  Radboud University Medical Center, Department of Surgery, Nijmegen, The Netherlands (GRID:grid.10417.33) (ISNI:0000 0004 0444 9382) 
19  University of Groningen and University Medical Center Groningen, Department of Surgery, Groningen, The Netherlands (GRID:grid.4494.d) (ISNI:0000 0000 9558 4598) 
20  Isala Ziekenhuis, Department of Surgery, Zwolle, The Netherlands (GRID:grid.4494.d) 
21  Reinier de Graaf Gasthuis, Department of Surgery, Delft, The Netherlands (GRID:grid.415868.6) (ISNI:0000 0004 0624 5690) 
22  Amphia Ziekenhuis, Department of Surgery, Breda, The Netherlands (GRID:grid.413711.1) 
23  Tjongerschans, Department of Surgery, Heerenveen, The Netherlands (GRID:grid.413711.1) 
24  University Medical Center Utrecht, Utrecht University, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands (GRID:grid.413711.1) 
Pages
389
Publication year
2020
Publication date
Dec 2020
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-020-4167-9
ProQuest document ID
2730331786
Copyright
© The Author(s). 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.