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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.
- acute pancreatitis
- gallstones
- endoscopic ultrasonography
- endoscopy
Data availability statement
Data are available on reasonable request. Requests for data can be made to the corresponding author. All requests will be discussed during a meeting of the Dutch Pancreatitis Study Group. After approval of the group, individual participant data that underlie the results reported in this article will be shared after deidentification. Related documents, such as the trial protocol and statistical analysis plan, will be available online immediately following publication without an end date to anyone who wishes to access the data.
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Data availability statement
Data are available on reasonable request. Requests for data can be made to the corresponding author. All requests will be discussed during a meeting of the Dutch Pancreatitis Study Group. After approval of the group, individual participant data that underlie the results reported in this article will be shared after deidentification. Related documents, such as the trial protocol and statistical analysis plan, will be available online immediately following publication without an end date to anyone who wishes to access the data.
Footnotes
Twitter @marcbesselink
Contributors All authors contributed to the conceptualisation and methodology. The investigation was performed by NDH and PMCS. MB, MGB, M-PGFA, OJB,TLB, DWdC, SMvD, HMvD, BvE, CvE, WE, PF, E-JvG, JvG, WLH, RAH, JEvH, JMJ, FJGMK, SK, ACP, RQ, RJdR, TCJS, TR, EJS, MPS, XJNMS, MPS, AT, WT, RT, DSU, NGV, RCV, FV, WvdV, RLJvW and BJMW contributed to patient recruitment, investigational treatment and the acquisition of data. TLB assessed the imaging. The formal analysis was performed by NDH, PMCS and NS. The manuscript was drafted by NDH. SAWB, MB, MGB, NJS, PMCS and HvS coauthored the writing. All authors have critically appraised the manuscript. MJB was the guarantor that supervised the study.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests 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.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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