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

Nora D Hallensleben*, Pauline M C Stassen, Nicolien J Schepers, Marc G Besselink, Marie-Paule G F Anten, Olaf J Bakker, Thomas L Bollen, David W da Costa, Sven M van Dijk, Hendrik M van Dullemen, Marcel G W Dijkgraaf, Brechje van Eijck, Casper H J van Eijck, Willemien Erkelens, Nicole S Erler, Paul Fockens, Erwin-Jan M van Geenen, Janneke van Grinsven, Wouter L Hazen, Robbert A HollemansJeanin E van Hooft, Jeroen M Jansen, Frank J G M Kubben, Sjoerd D Kuiken, Alexander C Poen, Rutger Quispel, Rogier J de Ridder, Tessa E H Römkens, Erik J Schoon, Matthijs P Schwartz, Tom C J Seerden, Xavier J N M Smeets, B W Marcel Spanier, Adriaan C I T L Tan, Willem J Thijs, Robin Timmer, Devica S Umans, Niels G Venneman, Robert C Verdonk, Frank P Vleggaar, Wim van de Vrie, Roy L J van Wanrooij, Ben J Witteman, the Dutch Pancreatitis Study Group, Hjalmar C van Santvoort, Stefan A W Bouwense, Marco J Bruno

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Scopus)

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 languageEnglish
Article numbergutjnl-2022-328258
Pages (from-to)1534-1542
Number of pages9
JournalGut
Volume72
Issue number8
Early online date27 Feb 2023
DOIs
Publication statusPublished - 1 Aug 2023

Bibliographical note

© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

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