Smits, F. Jasmijn http://orcid.org/0000-0002-1347-0218
,
Henry, Anne Claire
van Eijck, Casper H.
Besselink, Marc G.
Busch, Olivier R.
Arntz, Mark
Bollen, Thomas L.
van Delden, Otto M.
van den Heuvel, Daniel
van der Leij, Christiaan
van Lienden, Krijn P.
Moelker, Adriaan
Bonsing, Bert A.
Borel Rinkes, Inne H. M.
Bosscha, Koop
van Dam, R. M.
Festen, Sebastiaan
Groot Koerkamp, B.
van der Harst, Erwin
de Hingh, Ignace H.
Kazemier, Geert
Liem, Mike
van der Kolk, B. Marion
de Meijer, Vincent E.
Patijn, Gijs A.
Roos, Daphne
Schreinemakers, Jennifer M.
Wit, Fennie
van Werkhoven, C. Henri
Molenaar, I. Quintus
van Santvoort, Hjalmar C.
Funding for this research was provided by:
KWF Kankerbestrijding (8272)
Article History
Received: 2 December 2019
Accepted: 12 February 2020
First Online: 7 May 2020
Ethics approval and consent to participate
: This trial is designed and will be conducted in accordance to the requirements of the Helsinki Declaration and Good Clinical Practice. The aim of this trial is to evaluate the effect of the implementation of an algorithm for postoperative care on clinical outcomes after pancreatic resection. The intervention proposed in this trial was solely focused on the education of local clinicians on this best-practice algorithm. There is consensus amongst surgeons from every center of the Dutch Pancreatic Cancer Group and from the leading surgeons from three renowned international centers that the algorithm represents the best quality of care. By implementation of this algorithm we aim to trigger early detection and minimally invasive management of postoperative pancreatic fistula through education, to restructure the review of existing clinical data. The local medical ethical committees of the participating centers approved this study and waived the need for informed consent. Patients will be informed of the routine data collection to evaluate the quality of care [CitationRef removed]. We asked the principal investigator (i.e. cluster consent) of every participating center to sign a declaration of intent for participation before the start of this study. Primary approval was provided. Central ethical approval has been confirmed from the Medical Ethical Committees United (MEC-U), reference number W17.057 and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained. The appropriate committees from participating centers will be asked to review all substantial amendments to the study protocol.
: Not applicable.
: The authors declare that they have no competing interests.