TY - JOUR
T1 - Immediate versus postponed intervention for infected necrotizing pancreatitis
AU - Boxhoorn, Lotte
AU - van Dijk, Sven M.
AU - van Grinsven, Janneke
AU - Verdonk, Robert C.
AU - Boermeester, Marja A.
AU - Bollen, Thomas L.
AU - Bouwense, Stefan A. W.
AU - Bruno, Marco J.
AU - Cappendijk, Vincent C.
AU - Dejong, Cornelis H. C.
AU - van Duijvendijk, Peter
AU - van Eijck, Casper H. J.
AU - Fockens, Paul
AU - Francken, Michiel F. G.
AU - van Goor, Harry
AU - Hadithi, Muhammed
AU - Hallensleben, Nora D. L.
AU - Haveman, Jan Willem
AU - Jacobs, Maarten A. J. M.
AU - Jansen, Jeroen M.
AU - Kop, Marnix P. M.
AU - van Lienden, Krijn P.
AU - Manusama, Eric R.
AU - Mieog, Sven J. D.
AU - Molenaar, I. Quintus
AU - Nieuwenhuijs, Vincent B.
AU - Poen, Alexander C.
AU - Poley, Jan-Werner
AU - van de Poll, Marcel
AU - Quispel, Rutger
AU - Römkens, Tessa E. H.
AU - Schwartz, Matthijs P.
AU - Seerden, Tom C.
AU - Stommel, Martijn W. J.
AU - Straathof, Jan Willem A.
AU - Timmerhuis, Hester C.
AU - Venneman, Niels G.
AU - Voermans, Rogier P.
AU - van de Vrie, Wim
AU - Witteman, Ben J.
AU - Dijkgraaf, Marcel G. W.
AU - van Santvoort, Hjalmar C.
AU - Besselink, Marc G.
AU - Study group members AMC, null
AU - Stoker, Jaap
N1 - Funding Information: Supported by Fonds NutsOhra (grant no. 1404–044), the Netherlands, and the Amsterdam UMC, University of Amsterdam. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. Publisher Copyright: Copyright © 2021 Massachusetts Medical Society.
PY - 2021/10/7
Y1 - 2021/10/7
N2 - BACKGROUND Infected 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. METHODS We 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. RESULTS A 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. CONCLUSIONS This 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.
AB - BACKGROUND Infected 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. METHODS We 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. RESULTS A 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. CONCLUSIONS This 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.
UR - http://www.scopus.com/inward/record.url?scp=85116889505&partnerID=8YFLogxK
U2 - https://doi.org/10.1056/NEJMoa2100826
DO - https://doi.org/10.1056/NEJMoa2100826
M3 - Article
C2 - 34614330
SN - 0028-4793
VL - 385
SP - 1372
EP - 1381
JO - New England journal of medicine
JF - New England journal of medicine
IS - 15
ER -