Pancreas

Gut. 2023;72(8):1534–42

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, Römkens 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 BJ, van Santvoort HC, Bouwense SAW, Bruno MJ; Dutch Pancreatitis Study Group

Patient selection for urgent endoscopic retrograde cholangiopancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): A multicenter prospective study

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 multicenter, 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 end point 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 randomized 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 (interquartile range [IQR], 17–23 hours) after hospital presentation and at a median of 29 hours (IQR, 23–41 hours) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48 of 83 patients (58%), all of whom underwent immediate ERCP with ES. The primary end point occurred in 34 of 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% confidence interval [CI]: 0.67–1.29; 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 odds ratio = 1.03, 95% CI: 0.56–1.90, p = 0.92).

Conclusion: In patients with predicted severe acute biliary pancreatitis without cholangitis, urgent endoscopic ultrasonography-guided endoscopic retrograde cholangiopancreatography with endoscopic biliary sphincterotomy did not reduce the composite end point of major complications or mortality, as compared with conservative treatment in a historical control group.

DOI: 10.1136/gutjnl-2022-328258