Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study.
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Hallensleben Nora D, Stassen Pauline M C, Schepers Nicolien J, Besselink Marc G, Anten Marie-Paule G F, Bakker Olaf J, Bollen Thomas L, da Costa David W, van Dijk Sven M, van Dullemen Hendrik M, Dijkgraaf Marcel G W, van Eijck Brechje, van Eijck Casper H J, Erkelens Willemien, Erler Nicole S, Fockens Paul, van Geenen Erwin-Jan M, van Grinsven Janneke, Hazen Wouter L, Hollemans Robbert A, van Hooft Jeanin E, Jansen Jeroen M, Kubben Frank J G M, Kuiken Sjoerd D, Poen Alexander C, Quispel Rutger, de Ridder Rogier J, Römkens Tessa E H, Schoon Erik J, Schwartz Matthijs P, Seerden Tom C J, Smeets Xavier J N M, Spanier B W Marcel, Tan Adriaan C I T L, Thijs Willem J, Timmer Robin, Umans Devica S, Venneman Niels G, Verdonk Robert C, Vleggaar Frank P, van de Vrie Wim, van Wanrooij Roy L J, Witteman Ben J, van Santvoort Hjalmar C, Bouwense Stefan A W, Bruno Marco J, Dutch Pancreatitis Study Group
Аннотация
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.