Evidence map›Paper›PMID 32381031›Full record

ArticleTrials2020

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 Jasmijn Smits, Anne Claire Henry, Casper H van Eijck, Marc G Besselink, Olivier R Busch, Mark Arntz, Thomas L Bollen, Otto M van Delden, Daniel van den Heuvel, Christiaan van der Leij and 22 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
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  7. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 12 institutions in 1 country.

F Jasmijn SmitsDepartment of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.ORCID http://orcid.org/0000-0002-1347-0218
Anne Claire HenryDepartment of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.
Casper H van EijckDepartment of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Marc G BesselinkDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Olivier R BuschDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Mark ArntzDepartment of Radiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Thomas L BollenDepartment of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands.
Otto M van DeldenDepartment of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Daniel van den HeuvelDepartment of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands.
Christiaan van der LeijDepartment of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands.
Krijn P van LiendenDepartment of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Adriaan MoelkerDepartment of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Bert A BonsingDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Inne H M Borel RinkesDepartment of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.
Koop BosschaDepartment of Surgery, Jeroen Bosch Ziekenhuis, ´s-Hertogenbosch, The Netherlands.
R M van DamDepartment of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Sebastiaan FestenDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
B Groot KoerkampDepartment of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Erwin van der HarstDepartment of Surgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands.
Ignace H de HinghDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.
Geert KazemierDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, VU University, Amsterdam, The Netherlands.
Mike LiemDepartment of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.
B Marion van der KolkDepartment of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Vincent E de MeijerDepartment of Surgery, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.
Gijs A PatijnDepartment of Surgery, Isala Ziekenhuis, Zwolle, The Netherlands.
Daphne RoosDepartment of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.
Jennifer M SchreinemakersDepartment of Surgery, Amphia Ziekenhuis, Breda, The Netherlands.
Fennie WitDepartment of Surgery, Tjongerschans, Heerenveen, The Netherlands.
C Henri van WerkhovenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
I Quintus MolenaarDepartment of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.
Hjalmar C van SantvoortDepartment 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.
Dutch Pancreatic Cancer Group
Erasmus MC · NLRadboud University Nijmegen · NLUniversity Medical Center Utrecht · NLMaastricht University · NLLeiden University Medical Center · NLReinier de Graaf Hospital · NLSt. Antonius Ziekenhuis · NLUniversity Medical Center Groningen · NLUtrecht University · NLAmphia Ziekenhuis · NLAmsterdam University Medical Centers · NLMedisch Spectrum Twente · NL

Funding

KWF Kankerbestrijding 8272
6 · The paper itself

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 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 registrationNetherlands Trial Register: NL 6671. Registered on 16 December 2017.

Indexed as

AlgorithmsCost-Benefit AnalysisDelivery of Health CareDisease ManagementEarly DiagnosisEquivalence Trials as TopicFemaleHealth ResourcesHemorrhageHumansMaleMultiple Organ FailureNetherlandsPancreasPancreatectomyPancreatic Fistula

Identifiers

PMID32381031
PMCPMC7206814
OpenAlexW3023760440

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.