Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study

N.D. Hallensleben; P.M.C. Stassen; N.J. Schepers; M.G. Besselink; M.P.G.F. Anten; O.J. Bakker; T.L. Bollen; D.W. da Costa; S.M. van Dijk; H.M. van Dullemen; M.G.W. Dijkgraaf; B. van Eijck; C.H.J. van Eijck; W. Erkelens; N.S. Erler; P. Fockens; E.J.M. van Geenen; J. van Grinsven; W.L. Hazen; R.A. Hollemans; J.E. van Hooft; J.M. Jansen; F.J.G.M. Kubben; S.D. Kuiken; A.C. Poen; R. Quispel; R.J. de Ridder; T.E.H. Romkens; E.J. Schoon; M.P. Schwartz; T.C.J. Seerden; X.J.N.M. Smeets; B.W.M. Spanier; A.C.I.T.L. Tan; W.J. Thijs; R. Timmer; D.S. Umans; N.G. Venneman; R.C. Verdonk; F.P. Vleggaar; W. van de Vrie; R.L.J. van Wanrooij; B. Witteman; H.C. van Santvoort; S.A.W. Bouwense; M.J. Bruno; Dutch Pancreatitis Study Grp

doi:10.1136/gutjnl-2022-328258

Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study

N.D. Hallensleben^*, P.M.C. Stassen, N.J. Schepers, M.G. Besselink, M.P.G.F. Anten, O.J. Bakker, T.L. Bollen, D.W. da Costa, S.M. van Dijk, H.M. van Dullemen, M.G.W. Dijkgraaf, B. van Eijck, C.H.J. van Eijck, W. Erkelens, N.S. Erler, P. Fockens, E.J.M. van Geenen, J. van Grinsven, W.L. Hazen, R.A. HollemansJ.E. van Hooft, J.M. Jansen, F.J.G.M. Kubben, S.D. Kuiken, A.C. Poen, R. Quispel, R.J. de Ridder, T.E.H. Romkens, E.J. Schoon, M.P. Schwartz, T.C.J. Seerden, X.J.N.M. Smeets, B.W.M. Spanier, A.C.I.T.L. Tan, W.J. Thijs, R. Timmer, D.S. Umans, N.G. Venneman, R.C. Verdonk, F.P. Vleggaar, W. van de Vrie, R.L.J. van Wanrooij, B. Witteman, H.C. van Santvoort, S.A.W. Bouwense, M.J. Bruno, Dutch Pancreatitis Study Grp

^*Corresponding author for this work

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

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Abstract

Objective Routine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means of endoscopic ultrasonography (EUS) for stone/sludge detection may challenge these findings. Design A multicentre, prospective cohort study included patients with predicted severe acute biliary pancreatitis without cholangitis. Patients underwent urgent EUS, followed by ERCP with ES in case of common bile duct stones/sludge, within 24 hours after hospital presentation and within 72 hours after symptom onset. The primary endpoint was a composite of major complications or mortality within 6 months after inclusion. The historical control group was the conservative treatment arm (n=113) of the randomised APEC trial (Acute biliary Pancreatitis: urgent ERCP with sphincterotomy versus conservative treatment, patient inclusion 2013-2017) applying the same study design. Results Overall, 83 patients underwent urgent EUS at a median of 21 hours (IQR 17-23) after hospital presentation and at a median of 29 hours (IQR 23-41) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48/83 patients (58%), all of whom underwent immediate ERCP with ES. The primary endpoint occurred in 34/83 patients (41%) in the urgent EUS-guided ERCP group. This was not different from the 44% rate (50/113 patients) in the historical conservative treatment group (risk ratio (RR) 0.93, 95% CI 0.67 to 1.29; p=0.65). Sensitivity analysis to correct for baseline differences using a logistic regression model also showed no significant beneficial effect of the intervention on the primary outcome (adjusted OR 1.03, 95% CI 0.56 to 1.90, p=0.92). Conclusion In patients with predicted severe acute biliary pancreatitis without cholangitis, urgent EUS-guided ERCP with ES did not reduce the composite endpoint of major complications or mortality, as compared with conservative treatment in a historical control group. Trial registration number ISRCTN15545919.

Original language	English
Pages (from-to)	1534-1542
Number of pages	9
Journal	Gut
Volume	72
Issue number	8
Early online date	1 Feb 2023
DOIs	https://doi.org/10.1136/gutjnl-2022-328258
Publication status	Published - Aug 2023

Keywords

acute pancreatitis
gallstones
endoscopic ultrasonography
endoscopy
ULTRASONOGRAPHY
OBSTRUCTION
MANAGEMENT
GUIDELINE

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10.1136/gutjnl-2022-328258

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Cite this

Hallensleben, N. D., Stassen, P. M. C., Schepers, N. J., Besselink, M. G., Anten, M. P. G. F., Bakker, O. J., Bollen, T. L., da Costa, D. W., van Dijk, S. M., van Dullemen, H. M., Dijkgraaf, M. G. W., van Eijck, B., van Eijck, C. H. J., Erkelens, W., Erler, N. S., Fockens, P., van Geenen, E. J. M., van Grinsven, J., Hazen, W. L., ... Dutch Pancreatitis Study Grp (2023). Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study. Gut, 72(8), 1534-1542. https://doi.org/10.1136/gutjnl-2022-328258

@article{ba365e20ccb34a6aa04ef4e514af36af,

title = "Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study",

abstract = "Objective Routine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means of endoscopic ultrasonography (EUS) for stone/sludge detection may challenge these findings. Design A multicentre, prospective cohort study included patients with predicted severe acute biliary pancreatitis without cholangitis. Patients underwent urgent EUS, followed by ERCP with ES in case of common bile duct stones/sludge, within 24 hours after hospital presentation and within 72 hours after symptom onset. The primary endpoint was a composite of major complications or mortality within 6 months after inclusion. The historical control group was the conservative treatment arm (n=113) of the randomised APEC trial (Acute biliary Pancreatitis: urgent ERCP with sphincterotomy versus conservative treatment, patient inclusion 2013-2017) applying the same study design. Results Overall, 83 patients underwent urgent EUS at a median of 21 hours (IQR 17-23) after hospital presentation and at a median of 29 hours (IQR 23-41) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48/83 patients (58%), all of whom underwent immediate ERCP with ES. The primary endpoint occurred in 34/83 patients (41%) in the urgent EUS-guided ERCP group. This was not different from the 44% rate (50/113 patients) in the historical conservative treatment group (risk ratio (RR) 0.93, 95% CI 0.67 to 1.29; p=0.65). Sensitivity analysis to correct for baseline differences using a logistic regression model also showed no significant beneficial effect of the intervention on the primary outcome (adjusted OR 1.03, 95% CI 0.56 to 1.90, p=0.92). Conclusion In patients with predicted severe acute biliary pancreatitis without cholangitis, urgent EUS-guided ERCP with ES did not reduce the composite endpoint of major complications or mortality, as compared with conservative treatment in a historical control group. Trial registration number ISRCTN15545919.",

keywords = "acute pancreatitis, gallstones, endoscopic ultrasonography, endoscopy, ULTRASONOGRAPHY, OBSTRUCTION, MANAGEMENT, GUIDELINE",

author = "N.D. Hallensleben and P.M.C. Stassen and N.J. Schepers and M.G. Besselink and M.P.G.F. Anten and O.J. Bakker and T.L. Bollen and {da Costa}, D.W. and {van Dijk}, S.M. and {van Dullemen}, H.M. and M.G.W. Dijkgraaf and {van Eijck}, B. and {van Eijck}, C.H.J. and W. Erkelens and N.S. Erler and P. Fockens and {van Geenen}, E.J.M. and {van Grinsven}, J. and W.L. Hazen and R.A. Hollemans and {van Hooft}, J.E. and J.M. Jansen and F.J.G.M. Kubben and S.D. Kuiken and A.C. Poen and R. Quispel and {de Ridder}, R.J. and T.E.H. Romkens and E.J. Schoon and M.P. Schwartz and T.C.J. Seerden and X.J.N.M. Smeets and B.W.M. Spanier and A.C.I.T.L. Tan and W.J. Thijs and R. Timmer and D.S. Umans and N.G. Venneman and R.C. Verdonk and F.P. Vleggaar and {van de Vrie}, W. and {van Wanrooij}, R.L.J. and B. Witteman and {van Santvoort}, H.C. and S.A.W. Bouwense and M.J. Bruno and {Dutch Pancreatitis Study Grp}",

note = "Funding Information: JEvH received personal speakers fees from Medtronic, Abbvie, Cook and Boston Scientific outside of the submitted work. PF reports personal fees from Olympus and Cook Endoscopy outside the submitted work. MJB reports personal fees from Boston Scientific, Cook Medical, Pentax Medical and Mylan, and grants from Boston Scientific, Cook Medical, Pentax Medical, 3M, outside the submitted work. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2023",

month = aug,

doi = "10.1136/gutjnl-2022-328258",

language = "English",

volume = "72",

pages = "1534--1542",

journal = "Gut",

issn = "0017-5749",

publisher = "BMJ Publishing Group",

number = "8",

}

Hallensleben, ND, Stassen, PMC, Schepers, NJ, Besselink, MG, Anten, MPGF, Bakker, OJ, Bollen, TL, da Costa, DW, van Dijk, SM, van Dullemen, HM, Dijkgraaf, MGW, van Eijck, B, van Eijck, CHJ, Erkelens, W, Erler, NS, Fockens, P, van Geenen, EJM, van Grinsven, J, Hazen, WL, Hollemans, RA, van Hooft, JE, Jansen, JM, Kubben, FJGM, Kuiken, SD, Poen, AC, Quispel, R, de Ridder, RJ, Romkens, TEH, Schoon, EJ, Schwartz, MP, Seerden, TCJ, Smeets, XJNM, Spanier, BWM, Tan, ACITL, Thijs, WJ, Timmer, R, Umans, DS, Venneman, NG, Verdonk, RC, Vleggaar, FP, van de Vrie, W, van Wanrooij, RLJ, Witteman, B, van Santvoort, HC, Bouwense, SAW, Bruno, MJ & Dutch Pancreatitis Study Grp 2023, 'Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study', Gut, vol. 72, no. 8, pp. 1534-1542. https://doi.org/10.1136/gutjnl-2022-328258

Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study. / Hallensleben, N.D.; Stassen, P.M.C.; Schepers, N.J. et al.
In: Gut, Vol. 72, No. 8, 08.2023, p. 1534-1542.

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

TY - JOUR

T1 - Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study

AU - Hallensleben, N.D.

AU - Stassen, P.M.C.

AU - Schepers, N.J.

AU - Besselink, M.G.

AU - Anten, M.P.G.F.

AU - Bakker, O.J.

AU - Bollen, T.L.

AU - da Costa, D.W.

AU - van Dijk, S.M.

AU - van Dullemen, H.M.

AU - Dijkgraaf, M.G.W.

AU - van Eijck, B.

AU - van Eijck, C.H.J.

AU - Erkelens, W.

AU - Erler, N.S.

AU - Fockens, P.

AU - van Geenen, E.J.M.

AU - van Grinsven, J.

AU - Hazen, W.L.

AU - Hollemans, R.A.

AU - van Hooft, J.E.

AU - Jansen, J.M.

AU - Kubben, F.J.G.M.

AU - Kuiken, S.D.

AU - Poen, A.C.

AU - Quispel, R.

AU - de Ridder, R.J.

AU - Romkens, T.E.H.

AU - Schoon, E.J.

AU - Schwartz, M.P.

AU - Seerden, T.C.J.

AU - Smeets, X.J.N.M.

AU - Spanier, B.W.M.

AU - Tan, A.C.I.T.L.

AU - Thijs, W.J.

AU - Timmer, R.

AU - Umans, D.S.

AU - Venneman, N.G.

AU - Verdonk, R.C.

AU - Vleggaar, F.P.

AU - van de Vrie, W.

AU - van Wanrooij, R.L.J.

AU - Witteman, B.

AU - van Santvoort, H.C.

AU - Bouwense, S.A.W.

AU - Bruno, M.J.

AU - Dutch Pancreatitis Study Grp

N1 - Funding Information: JEvH received personal speakers fees from Medtronic, Abbvie, Cook and Boston Scientific outside of the submitted work. PF reports personal fees from Olympus and Cook Endoscopy outside the submitted work. MJB reports personal fees from Boston Scientific, Cook Medical, Pentax Medical and Mylan, and grants from Boston Scientific, Cook Medical, Pentax Medical, 3M, outside the submitted work. Publisher Copyright: © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2023/8

Y1 - 2023/8

N2 - Objective Routine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means of endoscopic ultrasonography (EUS) for stone/sludge detection may challenge these findings. Design A multicentre, prospective cohort study included patients with predicted severe acute biliary pancreatitis without cholangitis. Patients underwent urgent EUS, followed by ERCP with ES in case of common bile duct stones/sludge, within 24 hours after hospital presentation and within 72 hours after symptom onset. The primary endpoint was a composite of major complications or mortality within 6 months after inclusion. The historical control group was the conservative treatment arm (n=113) of the randomised APEC trial (Acute biliary Pancreatitis: urgent ERCP with sphincterotomy versus conservative treatment, patient inclusion 2013-2017) applying the same study design. Results Overall, 83 patients underwent urgent EUS at a median of 21 hours (IQR 17-23) after hospital presentation and at a median of 29 hours (IQR 23-41) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48/83 patients (58%), all of whom underwent immediate ERCP with ES. The primary endpoint occurred in 34/83 patients (41%) in the urgent EUS-guided ERCP group. This was not different from the 44% rate (50/113 patients) in the historical conservative treatment group (risk ratio (RR) 0.93, 95% CI 0.67 to 1.29; p=0.65). Sensitivity analysis to correct for baseline differences using a logistic regression model also showed no significant beneficial effect of the intervention on the primary outcome (adjusted OR 1.03, 95% CI 0.56 to 1.90, p=0.92). Conclusion In patients with predicted severe acute biliary pancreatitis without cholangitis, urgent EUS-guided ERCP with ES did not reduce the composite endpoint of major complications or mortality, as compared with conservative treatment in a historical control group. Trial registration number ISRCTN15545919.

AB - Objective Routine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means of endoscopic ultrasonography (EUS) for stone/sludge detection may challenge these findings. Design A multicentre, prospective cohort study included patients with predicted severe acute biliary pancreatitis without cholangitis. Patients underwent urgent EUS, followed by ERCP with ES in case of common bile duct stones/sludge, within 24 hours after hospital presentation and within 72 hours after symptom onset. The primary endpoint was a composite of major complications or mortality within 6 months after inclusion. The historical control group was the conservative treatment arm (n=113) of the randomised APEC trial (Acute biliary Pancreatitis: urgent ERCP with sphincterotomy versus conservative treatment, patient inclusion 2013-2017) applying the same study design. Results Overall, 83 patients underwent urgent EUS at a median of 21 hours (IQR 17-23) after hospital presentation and at a median of 29 hours (IQR 23-41) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48/83 patients (58%), all of whom underwent immediate ERCP with ES. The primary endpoint occurred in 34/83 patients (41%) in the urgent EUS-guided ERCP group. This was not different from the 44% rate (50/113 patients) in the historical conservative treatment group (risk ratio (RR) 0.93, 95% CI 0.67 to 1.29; p=0.65). Sensitivity analysis to correct for baseline differences using a logistic regression model also showed no significant beneficial effect of the intervention on the primary outcome (adjusted OR 1.03, 95% CI 0.56 to 1.90, p=0.92). Conclusion In patients with predicted severe acute biliary pancreatitis without cholangitis, urgent EUS-guided ERCP with ES did not reduce the composite endpoint of major complications or mortality, as compared with conservative treatment in a historical control group. Trial registration number ISRCTN15545919.

KW - acute pancreatitis

KW - gallstones

KW - endoscopic ultrasonography

KW - endoscopy

KW - ULTRASONOGRAPHY

KW - OBSTRUCTION

KW - MANAGEMENT

KW - GUIDELINE

U2 - 10.1136/gutjnl-2022-328258

DO - 10.1136/gutjnl-2022-328258

M3 - Article

C2 - 36849226

SN - 0017-5749

VL - 72

SP - 1534

EP - 1542

JO - Gut

JF - Gut

IS - 8

ER -