Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis

L. Boxhoorn; S.M. van Dijk; J. van Grinsven; R.C. Verdonk; M.A. Boermeester; T.L. Bollen; S.A.W. Bouwense; M.J. Bruno; V.C. Cappendijk; C.H.C. Dejong; P. van Duijvendijk; C.H.J. van Eijck; P. Fockens; M.F.G. Francken; H. van Goor; M. Hadithi; N.D.L. Hallensleben; J.W. Haveman; M.A.J.M. Jacobs; J.M. Jansen; M.P.M. Kop; K.P. van Lienden; E.R. Manusama; J.S.D. Mieog; I.Q. Molenaar; V.B. Nieuwenhuijs; A.C. Poen; J.W. Poley; M. van de Poll; R. Quispel; T.E.H. Romkens; M.P. Schwartz; T.C. Seerden; M.W.J. Stommel; J.W.A. Straathof; H.C. Timmerhuis; N.G. Venneman; R.P. Voermans; W. van de Vrie; B.J. Witteman; M.G.W. Dijkgraaf; H.C. van Santvoort; M.G. Besselink; Dutch Pancreatitis Study Grp

doi:10.1056/nejmoa2100826

Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis

L. Boxhoorn, S.M. van Dijk, J. van Grinsven, R.C. Verdonk, M.A. Boermeester, T.L. Bollen, S.A.W. Bouwense, M.J. Bruno, V.C. Cappendijk, C.H.C. Dejong, P. van Duijvendijk, C.H.J. van Eijck, P. Fockens, M.F.G. Francken, H. van Goor, M. Hadithi, N.D.L. Hallensleben, J.W. Haveman, M.A.J.M. Jacobs, J.M. JansenM.P.M. Kop, K.P. van Lienden, E.R. Manusama, J.S.D. Mieog, I.Q. Molenaar, V.B. Nieuwenhuijs, A.C. Poen, J.W. Poley, M. van de Poll, R. Quispel, T.E.H. Romkens, M.P. Schwartz, T.C. Seerden, M.W.J. Stommel, J.W.A. Straathof, H.C. Timmerhuis, N.G. Venneman, R.P. Voermans, W. van de Vrie, B.J. Witteman, M.G.W. Dijkgraaf, H.C. van Santvoort, M.G. Besselink^*, Dutch Pancreatitis Study Grp

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	1372-1381
Number of pages	10
Journal	New England Journal of Medicine
Volume	385
Issue number	15
DOIs	https://doi.org/10.1056/nejmoa2100826
Publication status	Published - 7 Oct 2021

Keywords

STEP-UP APPROACH
NECROSECTOMY
MANAGEMENT
CLASSIFICATION
NECROSIS
OUTCOMES

Access to Document

10.1056/nejmoa2100826

Cite this

Boxhoorn, L., van Dijk, S. M., van Grinsven, J., Verdonk, R. C., Boermeester, M. A., Bollen, T. L., Bouwense, S. A. W., Bruno, M. J., Cappendijk, V. C., Dejong, C. H. C., van Duijvendijk, P., van Eijck, C. H. J., Fockens, P., Francken, M. F. G., van Goor, H., Hadithi, M., Hallensleben, N. D. L., Haveman, J. W., Jacobs, M. A. J. M., ... Dutch Pancreatitis Study Grp (2021). Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis. New England Journal of Medicine, 385(15), 1372-1381. https://doi.org/10.1056/nejmoa2100826

@article{202b3bd1bfb4465dae6465decb2f1f34,

title = "Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis",

abstract = "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.",

keywords = "STEP-UP APPROACH, NECROSECTOMY, MANAGEMENT, CLASSIFICATION, NECROSIS, OUTCOMES",

author = "L. Boxhoorn and {van Dijk}, S.M. and {van Grinsven}, J. and R.C. Verdonk and M.A. Boermeester and T.L. Bollen and S.A.W. Bouwense and M.J. Bruno and V.C. Cappendijk and C.H.C. Dejong and {van Duijvendijk}, P. and {van Eijck}, C.H.J. and P. Fockens and M.F.G. Francken and {van Goor}, H. and M. Hadithi and N.D.L. Hallensleben and J.W. Haveman and M.A.J.M. Jacobs and J.M. Jansen and M.P.M. Kop and {van Lienden}, K.P. and E.R. Manusama and J.S.D. Mieog and I.Q. Molenaar and V.B. Nieuwenhuijs and A.C. Poen and J.W. Poley and {van de Poll}, M. and R. Quispel and T.E.H. Romkens and M.P. Schwartz and T.C. Seerden and M.W.J. Stommel and J.W.A. Straathof and H.C. Timmerhuis and N.G. Venneman and R.P. Voermans and {van de Vrie}, W. and B.J. Witteman and M.G.W. Dijkgraaf and {van Santvoort}, H.C. and M.G. Besselink and {Dutch Pancreatitis Study Grp}",

note = "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 {\textcopyright} 2021 Massachusetts Medical Society.",

year = "2021",

month = oct,

day = "7",

doi = "10.1056/nejmoa2100826",

language = "English",

volume = "385",

pages = "1372--1381",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "15",

}

Boxhoorn, L, van Dijk, SM, van Grinsven, J, Verdonk, RC, Boermeester, MA, Bollen, TL, Bouwense, SAW, Bruno, MJ, Cappendijk, VC, Dejong, CHC, van Duijvendijk, P, van Eijck, CHJ, Fockens, P, Francken, MFG, van Goor, H, Hadithi, M, Hallensleben, NDL, Haveman, JW, Jacobs, MAJM, Jansen, JM, Kop, MPM, van Lienden, KP, Manusama, ER, Mieog, JSD, Molenaar, IQ, Nieuwenhuijs, VB, Poen, AC, Poley, JW, van de Poll, M, Quispel, R, Romkens, TEH, Schwartz, MP, Seerden, TC, Stommel, MWJ, Straathof, JWA, Timmerhuis, HC, Venneman, NG, Voermans, RP, van de Vrie, W, Witteman, BJ, Dijkgraaf, MGW, van Santvoort, HC, Besselink, MG & Dutch Pancreatitis Study Grp 2021, 'Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis', New England Journal of Medicine, vol. 385, no. 15, pp. 1372-1381. https://doi.org/10.1056/nejmoa2100826

TY - JOUR

T1 - Immediate versus Postponed Intervention for Infected Necrotizing Pancreatitis

AU - Boxhoorn, L.

AU - van Dijk, S.M.

AU - van Grinsven, J.

AU - Verdonk, R.C.

AU - Boermeester, M.A.

AU - Bollen, T.L.

AU - Bouwense, S.A.W.

AU - Bruno, M.J.

AU - Cappendijk, V.C.

AU - Dejong, C.H.C.

AU - van Duijvendijk, P.

AU - van Eijck, C.H.J.

AU - Fockens, P.

AU - Francken, M.F.G.

AU - van Goor, H.

AU - Hadithi, M.

AU - Hallensleben, N.D.L.

AU - Haveman, J.W.

AU - Jacobs, M.A.J.M.

AU - Jansen, J.M.

AU - Kop, M.P.M.

AU - van Lienden, K.P.

AU - Manusama, E.R.

AU - Mieog, J.S.D.

AU - Molenaar, I.Q.

AU - Nieuwenhuijs, V.B.

AU - Poen, A.C.

AU - Poley, J.W.

AU - van de Poll, M.

AU - Quispel, R.

AU - Romkens, T.E.H.

AU - Schwartz, M.P.

AU - Seerden, T.C.

AU - Stommel, M.W.J.

AU - Straathof, J.W.A.

AU - Timmerhuis, H.C.

AU - Venneman, N.G.

AU - Voermans, R.P.

AU - van de Vrie, W.

AU - Witteman, B.J.

AU - Dijkgraaf, M.G.W.

AU - van Santvoort, H.C.

AU - Besselink, M.G.

AU - Dutch Pancreatitis Study Grp

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 - 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.

AB - 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.

KW - STEP-UP APPROACH

KW - NECROSECTOMY

KW - MANAGEMENT

KW - CLASSIFICATION

KW - NECROSIS

KW - OUTCOMES

U2 - 10.1056/nejmoa2100826

DO - 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 -