ORIGINAL ARTICLES
Design and International External Validation
Mungroop, Timothy H. MD∗; van Rijssen, L. Bengt MD∗; van Klaveren, David PhD†; Smits, F. Jasmijn MD‡; van Woerden, Victor MD§; Linnemann, Ralph J. MD¶; de Pastena, Matteo MD||; Klompmaker, Sjors MD∗; Marchegiani, Giovanni MD||; Ecker, Brett L. MD∗∗; van Dieren, Susan PhD∗; Bonsing, Bert MD∗∗; Busch, Olivier R. MD∗; van Dam, Ronald M. MD§; Erdmann, Joris MD††; van Eijck, Casper H. MD‡‡; Gerhards, Michael F. MD§§; van Goor, Harry MD¶¶; van der Harst, Erwin MD||||; de Hingh, Ignace H. MD∗∗∗; de Jong, Koert P. MD†††; Kazemier, Geert MD‡‡‡; Luyer, Misha MD∗∗∗; Shamali, Awad MD§§§; Barbaro, Salvatore MD§§§; Armstrong, Thomas MD§§§; Takhar, Arjun MD§§§; Hamady, Zaed MD§§§; Klaase, Joost MD¶¶¶; Lips, Daan J. MD||||||; Molenaar, I. Quintus MD‡; Nieuwenhuijs, Vincent B. MD¶; Rupert, Coen MD∗∗∗∗; van Santvoort, Hjalmar C. MD††††; Scheepers, Joris J. MD‡‡‡‡; van der Schelling, George P. MD§§§§; Bassi, Claudio MD||; Vollmer, Charles M. MD∗∗; Steyerberg, Ewout W. PhD‡‡; Abu Hilal, Mohammed MD§§§; Groot Koerkamp, Bas MD‡‡; Besselink, Marc G. MD, MSc, PhD∗
∗Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, the Netherlands
†Department of Public Health, Erasmus MC - University Medical Center Rotterdam, Rotterdam, the Netherlands
‡Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands
§Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands
¶Department of Surgery, Isala Clinics, Zwolle, the Netherlands
||Department of Surgery, Pancreas Institute of the University of Verona Hospital Trust, Verona, Italy
∗∗Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA
††Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands
‡‡Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands
§§Department of Surgery, OLVG Oost, Amsterdam, the Netherlands
¶¶Department of Surgery, Radboud University Medical Center, the Netherlands
||||Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands
∗∗∗Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands
†††Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands
‡‡‡Department of Surgery, VU University Medical Center, Amsterdam, the Netherlands
§§§Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
¶¶¶Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands
||||||Department of Surgery, Jeroen Bosch Hospital, ‘s Hertogenbosch, the Netherlands
∗∗∗∗Department of Surgery, Tjongerschans Hospital, Heerenveen, the Netherlands
††††Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands
‡‡‡‡Department of Surgery, Reinier de Graaf Gasthuis, Delft, the Netherlands
§§§§Department of Surgery, Amphia Hospital, Breda, the Netherlands.
Reprints: Marc G. Besselink, MD, MSc, PhD, Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Office G4-196, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands. E-mail: [emailprotected]; Timothy H. Mungroop, MD, Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Office G4-196, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands. E-mail: [emailprotected].
Mohammed Abu Hilal, Bas Groot Koerkamp, and Marc G. Besselink shared senior authorship.
Study conception and design: Mungroop, van Rijssen, Groot Koerkamp, Besselink
Acquisition of data: Mungroop, van Rijssen, Smits, van Woerden, DePastena, Marchegiani, Ecker, Bonsing, Busch, van Dam, Erdmann, van Eijck, Gerhards, van Goor, van der Harst, de Hingh, de Jong, Kazemier, Luyer, Shamali, Barbaro, Armstrong, Takhar, Hamady, Klaase, Lips, Molenaar, Nieuwenhuijs, Rupert, van Santvoort, Scheepers, van der Schelling, Bassi, Vollmer, Abu Hilal, Groot Koerkamp, Besselink.
Analysis and interpretation of data: Mungroop, van Rijssen, van Klaveren, Klompmaker, van Dieren, Vollmer, Steyerberg, Groot Koerkamp, Besselink
Drafting of manuscript: Mungroop, Groot Koerkamp, Besselink.
Critical revision: Mungroop, van Rijssen, van Klaveren, Smits, van Woerden, Linnemann, Klompmaker, Marchegiani, Ecker, DePastena, Bassi, Bonsing, Busch, van Dam, Erdmann, van Eijck, Gerhards, van Goor, van der Harst, de Hingh, de Jong, Kazemier, Luyer, Shamali, Barbaro, Armstrong, Takhar, Hamady, Klaase, Lips, Molenaar, Nieuwenhuijs, Rupert, van Santvoort, Scheepers, van der Schelling, Bassi, Vollmer, Steyerberg, Abu Hilal, Groot Koerkamp, Besselink.
This research was funded in part by a grant from the Dutch Cancer Society (grant number UVA2013-5842).
The authors have no conflicts of interest.
Annals of Surgery 269(5):p 937-943, May 2019. | DOI: 10.1097/SLA.0000000000002620
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Abstract
Objective:
The aim of this study was to develop an alternative fistula risk score (a-FRS) for postoperative pancreatic fistula (POPF) after pancreatoduodenectomy, without blood loss as a predictor.
Background:
Blood loss, one of the predictors of the original-FRS, was not a significant factor during 2 recent external validations.
Methods:
The a-FRS was developed in 2 databases: the Dutch Pancreatic Cancer Audit (18 centers) and the University Hospital Southampton NHS. Primary outcome was grade B/C POPF according to the 2005 International Study Group on Pancreatic Surgery (ISGPS) definition. The score was externally validated in 2 independent databases (University Hospital of Verona and University Hospital of Pennsylvania), using both 2005 and 2016 ISGPS definitions. The a-FRS was also compared with the original-FRS.
Results:
For model design, 1924 patients were included of whom 12% developed POPF. Three predictors were strongly associated with POPF: soft pancreatic texture [odds ratio (OR) 2.58, 95% confidence interval (95% CI) 1.80–3.69], small pancreatic duct diameter (per mm increase, OR: 0.68, 95% CI: 0.61–0.76), and high body mass index (BMI) (per kg/m2 increase, OR: 1.07, 95% CI: 1.04–1.11). Discrimination was adequate with an area under curve (AUC) of 0.75 (95% CI: 0.71–0.78) after internal validation, and 0.78 (0.74–0.82) after external validation. The predictive capacity of a-FRS was comparable with the original-FRS, both for the 2005 definition (AUC 0.78 vs 0.75, P = 0.03), and 2016 definition (AUC 0.72 vs 0.70, P = 0.05).
Conclusion:
The a-FRS predicts POPF after pancreatoduodenectomy based on 3 easily available variables (pancreatic texture, duct diameter, BMI) without blood loss and pathology, and was successfully validated for both the 2005 and 2016 POPF definition. The online calculator is available at www.pancreascalculator.com.
