TY - JOUR
T1 - Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2)
T2 - A multicentre prospective study
AU - Hallensleben, Nora D.
AU - Stassen, Pauline M. C.
AU - Schepers, Nicolien J.
AU - Besselink, Marc G.
AU - Anten, Marie-Paule G. F.
AU - Bakker, Olaf J.
AU - Bollen, Thomas L.
AU - da Costa, David W.
AU - van Dijk, Sven M.
AU - van Dullemen, Hendrik M.
AU - Dijkgraaf, Marcel G. W.
AU - van Eijck, Brechje
AU - van Eijck, Casper H. J.
AU - Erkelens, Willemien
AU - Erler, Nicole S.
AU - Fockens, Paul
AU - van Geenen, Erwin-Jan M.
AU - van Grinsven, Janneke
AU - Hazen, Wouter L.
AU - Hollemans, Robbert A.
AU - van Hooft, Jeanin E.
AU - Jansen, Jeroen M.
AU - Kubben, Frank J. G. M.
AU - Kuiken, Sjoerd D.
AU - Poen, Alexander C.
AU - Quispel, Rutger
AU - de Ridder, Rogier J.
AU - Römkens, Tessa E. H.
AU - Schoon, Erik J.
AU - Schwartz, Matthijs P.
AU - Seerden, Tom C. J.
AU - Smeets, Xavier J. N. M.
AU - Spanier, B. W. Marcel
AU - Tan, Adriaan C. I. T. L.
AU - Thijs, Willem J.
AU - Timmer, Robin
AU - Umans, Devica S.
AU - Venneman, Niels G.
AU - Verdonk, Robert C.
AU - Vleggaar, Frank P.
AU - van de Vrie, Wim
AU - van Wanrooij, Roy L. J.
AU - Witteman, Ben J.
AU - van Santvoort, Hjalmar C.
AU - Bouwense, Stefan A. W.
AU - Bruno, Marco J.
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 - 2023/8/1
Y1 - 2023/8/1
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 - endoscopic ultrasonography
KW - endoscopy
KW - gallstones
UR - http://www.scopus.com/inward/record.url?scp=85152203793&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/gutjnl-2022-328258
DO - https://doi.org/10.1136/gutjnl-2022-328258
M3 - Article
C2 - 36849226
SN - 0017-5749
VL - 72
SP - 1534
EP - 1542
JO - Gut
JF - Gut
IS - 8
M1 - gutjnl-2022-328258
ER -