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
Abstract
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 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- 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. postpancreatectomy 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.
Authors 31
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University Medical Center Utrecht
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Universitair Medisch Centrum Utrecht
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University Medical Center Utrecht
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Universitair Medisch Centrum Utrecht
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Affiliation as printed
Erasmus MC
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Amsterdam University Medical Centers
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Amsterdam Universitair Medische Centra
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Amsterdam University Medical Centers
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Amsterdam Universitair Medische Centra
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Radboud University Medical Center
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Radboudumc
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St. Antonius Ziekenhuis · Antonius Ziekenhuis
Affiliation as printed
Sint Antonius Ziekenhuis
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Amsterdam University Medical Centers
Affiliation as printed
Amsterdam Universitair Medische Centra
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St. Antonius Ziekenhuis · Antonius Ziekenhuis
Affiliation as printed
Sint Antonius Ziekenhuis
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Maastricht University Medical Centre
Affiliation as printed
Maastricht Universitair Medisch Centrum+
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Amsterdam University Medical Centers
Affiliation as printed
Amsterdam Universitair Medische Centra
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Affiliation as printed
Erasmus MC
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Bert A. Bonsing Aachen
Leiden University Medical Center
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Leids Universitair Medisch Centrum
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University Medical Center Utrecht
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Universitair Medisch Centrum Utrecht
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Affiliation as printed
Jeroen Bosch Ziekenhuis
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Maastricht University Medical Centre
Affiliation as printed
Maastricht Universitair Medisch Centrum+
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Sebastiaan Festen Aachen
Leiden University Medical Center · Maastricht University Medical Centre · University Medical Center Utrecht · OLVG · Amsterdam University Medical Centers
Affiliation as printed
OLVG
Amsterdam Universitair Medische Centra
Amsterdam Universitair Medische Centra OR Busch
Leids Universitair Medisch Centrum IHM Borel Rinkes Universitair Medisch Centrum Utrecht
Maastricht Universitair Medisch Centrum+ KP van Lienden Amsterdam Universitair Medische Centra
OM van Delden Amsterdam Universitair Medische Centra
Universitair Medisch Centrum Utrecht
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Affiliation as printed
Erasmus MC
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Affiliation as printed
Maasstad Ziekenhuis
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Affiliation as printed
Catharina Ziekenhuis
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Amsterdam University Medical Centers
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Amsterdam Universitair Medische Centra
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Affiliation as printed
Medisch Spectrum Twente
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Radboud University Medical Center
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Radboudumc
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University Medical Center Groningen
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Universitair Medisch Centrum Groningen
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Affiliation as printed
Isala
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Affiliation as printed
Reinier de Graaf Gasthuis
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Affiliation as printed
Amphia Ziekenhuis
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Affiliation as printed
Tjongerschans
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Affiliation as printed
Universiteit Utrecht
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University Medical Center Utrecht
Affiliation as printed
Universitair Medisch Centrum Utrecht
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University Medical Center Utrecht
Affiliation as printed
Universitair Medisch Centrum Utrecht
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