Long-Term Outcome of Immediate Versus Postponed Intervention in Patients With Infected Necrotizing Pancreatitis (POINTER): Multicenter Randomized Trial.

Autor:	Van Veldhuisen CL; Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands.; Department of Research and Development, St. Antonius Hospital, Nieuwegein, The Netherlands., Sissingh NJ; Department of Research and Development, St. Antonius Hospital, Nieuwegein, The Netherlands.; Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands., Boxhoorn L; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands.; Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands., van Dijk SM; Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands., van Grinsven J; Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands., Verdonk RC; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands., Boermeester MA; Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands., Bouwense SAW; Department of Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands., Bruno MJ; Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, The Netherlands., Cappendijk VC; Department of Radiology, Jeroen Bosch Hospital, Den Bosch, The Netherlands., van Duijvendijk P; Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands., van Eijck CHJ; Department of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands., Fockens P; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands.; Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands., van Goor H; Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Hadithi M; Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands., Haveman JW; Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Jacobs MAJM; Department of Gastroenterology and Hepatology, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands., Jansen JM; Department of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands., Kop MPM; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands.; Department of Radiology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands., Manusama ER; Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, The Netherlands., Mieog JSD; Department of Surgery, Leiden University Medical Centre, Leiden, The Netherlands., Molenaar IQ; Department of Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands., Nieuwenhuijs VB; Department of Surgery, Isala Clinics, Zwolle, The Netherlands., Poen AC; Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, The Netherlands., Poley JW; Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands., Quispel R; Department of Gastroenterology and Hepatology, Reinier de Graaf Group, Delft, The Netherlands., Römkens TEH; Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, The Netherlands., Schwartz MP; Department of Gastroenterology and Hepatology, Meander Medical Centre, Amersfoort, The Netherlands., Seerden TC; Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands., Dijkgraaf MGW; Department of Epidemiology and Data Science, Amsterdam UMC, location University of Amsterdam, Amsterdam Public Health, Amsterdam, The Netherlands., Stommel MWJ; Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Straathof JWA; Department of Gastroenterology and Hepatology, Máxima Medical Centre, Veldhoven, The Netherlands., Venneman NG; Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands., Voermans RP; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands.; Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands., van Hooft JE; Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands., van Santvoort HC; Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.; Department of Surgery, University Medical Center Utrecht, The Netherlands., Besselink MG; Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Gastroenterology Endocrinology Metabolism, The Netherlands.
Jazyk:	angličtina
Zdroj:	Annals of surgery [Ann Surg] 2024 Apr 01; Vol. 279 (4), pp. 671-678. Date of Electronic Publication: 2023 Jul 17.
DOI:	10.1097/SLA.0000000000006001
Abstrakt:	Objective: To compare the long-term outcomes of immediate drainage versus the postponed-drainage approach in patients with infected necrotizing pancreatitis. Background: In the randomized POINTER trial, patients assigned to the postponed-drainage approach using antibiotic treatment required fewer interventions, as compared with immediate drainage, and over a third were treated without any intervention. Methods: Clinical data of those patients alive after the initial 6-month follow-up were re-evaluated. The primary outcome was a composite of death and major complications. Results: Out of 104 patients, 88 were re-evaluated with a median follow-up of 51 months. After the initial 6-month follow-up, the primary outcome occurred in 7 of 47 patients (15%) in the immediate-drainage group and 7 of 41 patients (17%) in the postponed-drainage group (RR 0.87, 95% CI 0.33-2.28; P =0.78). Additional drainage procedures were performed in 7 patients (15%) versus 3 patients (7%) (RR 2.03; 95% CI 0.56-7.37; P =0.34). The median number of additional interventions was 0 (IQR 0-0) in both groups ( P =0.028). In the total follow-up, the median number of interventions was higher in the immediate-drainage group than in the postponed-drainage group (4 vs. 1, P =0.001). Eventually, 14 of 15 patients (93%) in the postponed-drainage group who were successfully treated in the initial 6-month follow-up with antibiotics and without any intervention remained without intervention. At the end of follow-up, pancreatic function and quality of life were similar. Conclusions: Also, during long-term follow-up, a postponed-drainage approach using antibiotics in patients with infected necrotizing pancreatitis results in fewer interventions as compared with immediate drainage and should therefore be the preferred approach. Trial Registration: ISRCTN33682933. Competing Interests: M.G.B.: grants from Ethicon Endo-Surgery and Medtronic. M.A.B. grants from Ipsen, New Compliance, Mylan, grants and personal fees from Johnson & Johnson, Acelity/KCI, and personal fees from Bard, Gore, Smith & Nephew. M.J.B.: consultant for Boston Scientific, Cook Medical, and Pentax Medical, financial support from Boston Scientific, Cook Medical, Pentax Medical, InterScope, 3M, and Mylan. P.F.: personal fees from Cook Medical, Ethicon Endo-surgery, and Olympus Medical. J.E.v.H.: grants and personal fees from Prion Medical, Cook Medical, and Olympus. J.P.: personal and other fees from Cook Endoscopy, Boston Scientific, and Pentax Medical. R.P. Voermans: grants and personal fees from Boston Scientific and grants from Zambon. All financial relationships were outside the submitted work. The remaining authors no conflicts of interest. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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