• N. Engl. J. Med. · Oct 2021

    Randomized Controlled Trial Multicenter Study Comparative Study

    Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis.

    • Lotte Boxhoorn, Sven M van Dijk, Janneke van Grinsven, Robert C Verdonk, Marja A Boermeester, Thomas L Bollen, BouwenseStefan A WSAWFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of A, Marco J Bruno, Vincent C Cappendijk, DejongCornelis H CCHCFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of A, Peter van Duijvendijk, van EijckCasper H JCHJFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of , Paul Fockens, Michiel F G Francken, Harry van Goor, Muhammed Hadithi, HallenslebenNora D LNDLFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of, Jan Willem Haveman, Maarten A J M Jacobs, Jeroen M Jansen, Marnix P M Kop, Krijn P van Lienden, Eric R Manusama, MieogJ Sven DJSDFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of Amster, I Quintus Molenaar, Vincent B Nieuwenhuijs, Alexander C Poen, Jan-Werner Poley, van de PollMarcelMFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of Amst, Rutger Quispel, RömkensTessa E HTEHFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of Ams, Matthijs P Schwartz, Tom C Seerden, StommelMartijn W JMWJFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of A, Jan Willem A Straathof, Hester C Timmerhuis, Niels G Venneman, Rogier P Voermans, Wim van de Vrie, Ben J Witteman, DijkgraafMarcel G WMGWFrom the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of , Hjalmar C van Santvoort, Marc G Besselink, and Dutch Pancreatitis Study Group.
    • From the Departments of Gastroenterology and Hepatology (L.B., P.F., R.P.V.), Surgery (S.M.D., J.G., M.A.B., M.F.G.F., M.G.B.), Radiology (M.P.M.K., K.P.L.), and Epidemiology and Data Science (M.G.W.D.), Amsterdam UMC, University of Amsterdam, and the Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Amsterdam (M.A.J.M.J.), Amsterdam Gastroenterology Endocrinology Metabolism, and the Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis (J.M.J.), Amsterdam, the Departments of Research and Development (L.B., S.M.D., N.D.L.H., H.C.T.), Gastroenterology and Hepatology (R.C.V.), Radiology (T.L.B., K.P.L.), and Surgery (H.C.T., H.C.S.), St. Antonius Hospital, Nieuwegein, the Department of Surgery, Maastricht University Medical Center, Maastricht (S.A.W.B., C.H.C.D., M.P.), the Departments of Gastroenterology and Hepatology (M.J.B., J.-W.P.), and Surgery (C.H.J.E.), Erasmus MC University Medical Center, and the Department of Gastroenterology and Hepatology, Maasstad Hospital (M.H.), Rotterdam, the Departments of Radiology (V.C.C.), and Gastroenterology and Hepatology (T.E.H.R.), Jeroen Bosch Hospital, Den Bosch, the Department of Surgery, Gelre Hospitals, Apeldoorn (P.D.), the Department of Surgery, Radboud University Medical Center, Nijmegen (H.G., M.W.J.S.), the Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen (J.W.H.), the Department of Surgery, Medical Center Leeuwarden, Leeuwarden (E.R.M.), the Department of Surgery, Leiden University Medical Center, Leiden (J.S.D.M.), the Department of Surgery, University Medical Center Utrecht, Utrecht (I.Q.M., H.C.S.), the Departments of Surgery (V.B.N.), and Gastroenterology and Hepatology (A.C.P.), Isala Clinics, Zwolle, the Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft (R.Q.), the Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort (M.P.S.), the Department of Gastroenterology and Hepatology, Amphia Hospital, Breda (T.C.S.), the Department of Gastroenterology and Hepatology, Maxima Medical Center, Veldhoven (J.W.A.S.), the Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede (N.G.V.), the Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht (W.V.), and the Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede (B.J.W.) - all in the Netherlands.
    • N. Engl. J. Med. 2021 Oct 7; 385 (15): 1372-1381.

    BackgroundInfected necrotizing pancreatitis is a potentially lethal disease that is treated with the use of a step-up approach, with catheter drainage often delayed until the infected necrosis is encapsulated. Whether outcomes could be improved by earlier catheter drainage is unknown.MethodsWe conducted a multicenter, randomized superiority trial involving patients with infected necrotizing pancreatitis, in which we compared immediate drainage within 24 hours after randomization once infected necrosis was diagnosed with drainage that was postponed until the stage of walled-off necrosis was reached. The primary end point was the score on the Comprehensive Complication Index, which incorporates all complications over the course of 6 months of follow-up.ResultsA total of 104 patients were randomly assigned to immediate drainage (55 patients) or postponed drainage (49 patients). The mean score on the Comprehensive Complication Index (scores range from 0 to 100, with higher scores indicating more severe complications) was 57 in the immediate-drainage group and 58 in the postponed-drainage group (mean difference, -1; 95% confidence interval [CI], -12 to 10; P = 0.90). Mortality was 13% in the immediate-drainage group and 10% in the postponed-drainage group (relative risk, 1.25; 95% CI, 0.42 to 3.68). The mean number of interventions (catheter drainage and necrosectomy) was 4.4 in the immediate-drainage group and 2.6 in the postponed-drainage group (mean difference, 1.8; 95% CI, 0.6 to 3.0). In the postponed-drainage group, 19 patients (39%) were treated conservatively with antibiotics and did not require drainage; 17 of these patients survived. The incidence of adverse events was similar in the two groups.ConclusionsThis trial did not show the superiority of immediate drainage over postponed drainage with regard to complications in patients with infected necrotizing pancreatitis. Patients randomly assigned to the postponed-drainage strategy received fewer invasive interventions. (Funded by Fonds NutsOhra and Amsterdam UMC; POINTER ISRCTN Registry number, ISRCTN33682933.).Copyright © 2021 Massachusetts Medical Society.

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