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

F.J. Smits, A.C. Henry, C.H. van Eijck, M.G. Besselink, O.R. Busch, M. Arntz, T.L. Bollen, O.M. van Delden, D. van den Heuvel, C. van der Leij, K.P. van Lienden, A. Moelker, B.A. Bonsing, I.H.M.B. Rinkes, K. Bosscha, R.M. van Dam, S. Festen, B.G. Koerkamp, E. van der Harst, I.H. de HinghG. Kazemier, M. Liem, B.M. van der Kolk, V.E. de Meijer, G.A. Patijn, D. Roos, J.M. Schreinemakers, F. Wit, C.H. van Werkhoven, I.Q. Molenaar, H.C. van Santvoort*, Dutch Pancreatic Canc Grp

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BackgroundPancreatic 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.MethodsThis 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 22months, 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 90days after pancreatic resection.DiscussionIt 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 registrationNetherlands Trial Register: NL 6671. Registered on 16 December 2017.
Original languageEnglish
Article number389
Number of pages16
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 7 May 2020

Keywords

  • classification
  • complications
  • cost-effectiveness
  • definition
  • education
  • guidelines
  • international study-group
  • pancreaticoduodenectomy
  • sample-size
  • surgery
  • PANCREATICODUODENECTOMY
  • DEFINITION
  • SURGERY
  • COST-EFFECTIVENESS
  • GUIDELINES
  • CLASSIFICATION
  • EDUCATION
  • INTERNATIONAL STUDY-GROUP
  • COMPLICATIONS
  • SAMPLE-SIZE

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