Timothy H Mungroop1, Sjors Klompmaker1, Ulrich F Wellner2,3, Ewout W Steyerberg4, Andrea Coratti5, Mathieu D'Hondt6, Matteo de Pastena7, Safi Dokmak8, Igor Khatkov9, Olivier Saint-Marc10, Uwe Wittel11, Mohammed Abu Hilal12, David Fuks13, Ignasi Poves14, Tobias Keck2,3, Ugo Boggi15, Marc G Besselink1. 1. Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, The Netherlands. 2. Clinic of Surgery, UKSH Campus Lübeck, Lübeck, Germany. 3. Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) Studien-, Dokumentations- und Qualitätszentrum (StuDoQ|Pancreas), Germany. 4. Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands. 5. Department of Oncology and Robotic Surgery, Careggi University Hospital, Florence, Italy. 6. Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, Kortrijk, Belgium. 7. Department of Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy. 8. Department of HPB Surgery and Liver Transplantation, Beaujon Hospital, Clichy, France. 9. Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russia. 10. Department of Surgery, Centre Hospitalier Régional Orleans, Orleans, France. 11. Department of Visceral and General Surgery, University of Freiburg Medical Center, Freiburg, Germany. 12. Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom. 13. Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France. 14. Department of Surgery, Hospital del Mar, Barcelona, Spain. 15. Division of General and Transplant Surgery, University of Pisa, Pisa, Italy.
Abstract
OBJECTIVE: The aim of the study was to validate and optimize the alternative Fistula Risk Score (a-FRS) for patients undergoing minimally invasive pancreatoduodenectomy (MIPD) in a large pan-European cohort. BACKGROUND: MIPD may be associated with an increased risk of postoperative pancreatic fistula (POPF). The a-FRS could allow for risk-adjusted comparisons in research and improve preventive strategies for high-risk patients. The a-FRS, however, has not yet been validated specifically for laparoscopic, robot-assisted, and hybrid MIPD. METHODS: A validation study was performed in a pan-European cohort of 952 consecutive patients undergoing MIPD (543 laparoscopic, 258 robot-assisted, 151 hybrid) in 26 centers from 7 countries between 2007 and 2017. The primary outcome was POPF (International Study Group on Pancreatic Surgery grade B/C). Model performance was assessed using the area under the receiver operating curve (AUC; discrimination) and calibration plots. Validation included univariable screening for clinical variables that could improve performance. RESULTS: Overall, 202 of 952 patients (21%) developed POPF after MIPD. Before adjustment, the original a-FRS performed moderately (AUC 0.68) and calibration was inadequate with systematic underestimation of the POPF risk. Single-row pancreatojejunostomy (odds ratio 4.6, 95 confidence interval [CI] 2.8-7.6) and male sex (odds ratio 1.9, 95 CI 1.4-2.7) were identified as important risk factors for POPF in MIPD. The updated a-FRS, consisting of body mass index, pancreatic texture, duct size, and male sex, showed good discrimination (AUC 0.75, 95 CI 0.71-0.79) and adequate calibration. Performance was adequate for laparoscopic, robot-assisted, and hybrid MIPD and open pancreatoduodenectomy. CONCLUSIONS: The updated a-FRS (www.pancreascalculator.com) now includes male sex as a risk factor and is validated for both MIPD and open pancreatoduodenectomy. The increased risk of POPF in laparoscopic MIPD was associated with single-row pancreatojejunostomy, which should therefore be discouraged.
OBJECTIVE: The aim of the study was to validate and optimize the alternative Fistula Risk Score (a-FRS) for patients undergoing minimally invasive pancreatoduodenectomy (MIPD) in a large pan-European cohort. BACKGROUND: MIPD may be associated with an increased risk of postoperative pancreatic fistula (POPF). The a-FRS could allow for risk-adjusted comparisons in research and improve preventive strategies for high-risk patients. The a-FRS, however, has not yet been validated specifically for laparoscopic, robot-assisted, and hybrid MIPD. METHODS: A validation study was performed in a pan-European cohort of 952 consecutive patients undergoing MIPD (543 laparoscopic, 258 robot-assisted, 151 hybrid) in 26 centers from 7 countries between 2007 and 2017. The primary outcome was POPF (International Study Group on Pancreatic Surgery grade B/C). Model performance was assessed using the area under the receiver operating curve (AUC; discrimination) and calibration plots. Validation included univariable screening for clinical variables that could improve performance. RESULTS: Overall, 202 of 952 patients (21%) developed POPF after MIPD. Before adjustment, the original a-FRS performed moderately (AUC 0.68) and calibration was inadequate with systematic underestimation of the POPF risk. Single-row pancreatojejunostomy (odds ratio 4.6, 95 confidence interval [CI] 2.8-7.6) and male sex (odds ratio 1.9, 95 CI 1.4-2.7) were identified as important risk factors for POPF in MIPD. The updated a-FRS, consisting of body mass index, pancreatic texture, duct size, and male sex, showed good discrimination (AUC 0.75, 95 CI 0.71-0.79) and adequate calibration. Performance was adequate for laparoscopic, robot-assisted, and hybrid MIPD and open pancreatoduodenectomy. CONCLUSIONS: The updated a-FRS (www.pancreascalculator.com) now includes male sex as a risk factor and is validated for both MIPD and open pancreatoduodenectomy. The increased risk of POPF in laparoscopic MIPD was associated with single-row pancreatojejunostomy, which should therefore be discouraged.