Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study
Authors: 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 
Published: February 2023

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.