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Randomized Controlled Trial Multicenter Study
Pancreatogastrostomy Versus Pancreatojejunostomy for RECOnstruction After PANCreatoduodenectomy (RECOPANC, DRKS 00000767): Perioperative and Long-term Results of a Multicenter Randomized Controlled Trial.
- Tobias Keck, U F Wellner, M Bahra, F Klein, O Sick, M Niedergethmann, T J Wilhelm, S A Farkas, T Börner, C Bruns, A Kleespies, J Kleeff, A L Mihaljevic, W Uhl, A Chromik, V Fendrich, K Heeger, W Padberg, A Hecker, U P Neumann, K Junge, J C Kalff, T R Glowka, J Werner, P Knebel, P Piso, M Mayr, J Izbicki, Y Vashist, P Bronsert, T Bruckner, R Limprecht, M K Diener, I Rossion, I Wegener, and U T Hopt.
- *Klinik für Chirurgie, UKSH Campus Lübeck, Lübeck, Germany †Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg, Freiburg, Germany ‡Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Charité - Universitätsmedizin Berlin - Campus Virchow-Klinikum, Berlin, Germany §Chirurgische Klinik, Universitätsmedizin Mannheim, Mannheim, Germany ¶Klinik für Chirurgie, Universitätsklinikum Regensburg, Regensburg, Germany ||Klinik für Allgemeine, Viszeral-, Transplantations-, Gefäß- und Thoraxchirurgie, Klinikum der Universität München, Munich, Germany **Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München und CHIR-Net München, Munich, Germany ††Chirurgische Klinik, St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Bochum, Germany ‡‡Klinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Marburg, Marburg, Germany §§Klinik für Allgemein-, Viszeral-, Thorax-, Transplantations- und Kinderchirurgie des Universitätsklinikums Gießen, Gießen, Germany ¶¶Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Aachen, Germany ||||Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Bonn, Bonn, Germany ***Abteilung für Allgemeine, Viszerale und Transplantationschirurgie, Universität Heidelberg, Heidelberg, Germany †††Klinik für Allgemein- und Viszeralchirurgie, Krankenhaus Barmherzige Brüder, Regensburg, Germany ‡‡‡Klinik und Poliklinik für Allgemein-, Viszeral- und Thoraxchirurgie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany §§§Institut für Pathologie, Universitätsklinikum Freiburg, Freiburg, Germany ¶¶¶Comprehensive Cancer Center Freiburg, Freiburg Germany ||||||Institut für Medizinische Biometrie und Informatik (IMBI), Universität Heidelberg, Heidelberg, Germany ****Studienzentrum der Deutschen Gesellschaft für Chirurgie
- Ann. Surg. 2016 Mar 1; 263 (3): 440-9.
ObjectivesTo assess pancreatic fistula rate and secondary endpoints after pancreatogastrostomy (PG) versus pancreatojejunostomy (PJ) for reconstruction in pancreatoduodenectomy in the setting of a multicenter randomized controlled trial.BackgroundPJ and PG are established methods for reconstruction in pancreatoduodenectomy. Recent prospective trials suggest superiority of the PG regarding perioperative complications.MethodsA multicenter prospective randomized controlled trial comparing PG with PJ was conducted involving 14 German high-volume academic centers for pancreatic surgery. The primary endpoint was clinically relevant postoperative pancreatic fistula. Secondary endpoints comprised perioperative outcome and pancreatic function and quality of life measured at 6 and 12 months of follow-up.ResultsFrom May 2011 to December 2012, 440 patients were randomized, and 320 were included in the intention-to-treat analysis. There was no significant difference in the rate of grade B/C fistula after PG versus PJ (20% vs 22%, P = 0.617). The overall incidence of grade B/C fistula was 21%, and the in-hospital mortality was 6%. Multivariate analysis of the primary endpoint disclosed soft pancreatic texture (odds ratio: 2.1, P = 0.016) as the only independent risk factor. Compared with PJ, PG was associated with an increased rate of grade A/B bleeding events, perioperative stroke, less enzyme supplementation at 6 months, and improved results in some quality of life parameters.ConclusionsThe rate of grade B/C fistula after PG versus PJ was not different. There were more postoperative bleeding events with PG. Perioperative morbidity and mortality of pancreatoduodenectomy seem to be underestimated, even in the high-volume center setting.
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