Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis

医学 排水 外科 随机化 并发症 胰腺炎 置信区间 随机对照试验 内科学 生态学 生物
作者
Lotte Boxhoorn,Sven M. van Dijk,Janneke van Grinsven,Robert C. Verdonk,Marja A. Boermeester,Thomas L. Bollen,Willem A. Bemelman,Marco J. Bruno,Vincent C. Cappendijk,C.A.J. de Jong,Peter van Duijvendijk,Casper H.J. van Eijck,Paul Fockens,Michiel F.G. Francken,Harry van Goor,Muhammed Hadithi,Nora D. Hallensleben,Jan Willem Haveman,Maarten Jacobs,Jeroen M. Jansen,Marnix P.M. Kop,Krijn P. van Lienden,Eric R. Manusama,J. Sven D. Mieog,I. Quintus Molenaar,Vincent B. Nieuwenhuijs,Alexander C. Poen,Jan‐Werner Poley,Marcel C.G. van de Poll,Rutger Quispel,Tessa E H Römkens,Matthijs P. Schwartz,Tom Seerden,Martijn W.J. Stommel,Jan Willem Straathof,Hester C. Timmerhuis,Niels G. Venneman,Rogier P. Voermans,Wim van de Vrie,Ben J.�M. Witteman,Marcel G. W. Dijkgraaf,Hjalmar C. van Santvoort,Marc G. Besselink
出处
期刊:The New England Journal of Medicine [New England Journal of Medicine]
卷期号:385 (15): 1372-1381 被引量:146
标识
DOI:10.1056/nejmoa2100826
摘要

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.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.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.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. (Funded by Fonds NutsOhra and Amsterdam UMC; POINTER ISRCTN Registry number, ISRCTN33682933.).
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