Background

The optimal timing of endoscopic retrograde cholangiopancreatography (ERCP) in patients with mild-to-moderate acute cholangitis remains uncertain.

Objective

To compare the clinical outcomes of urgent ERCP performed within 24 hours vs early ERCP performed within 24–48 hours in patients with mild to moderate acute cholangitis.

Design

Single-centre, open-label, randomised controlled trial. The primary outcome was 30-day mortality. Secondary outcomes included organ failure at day 3 and day 30, in-hospital mortality, length of hospital stay, reintervention rates, readmission rates and post-ERCP adverse events. The sample size calculation was based on a superiority hypothesis, assuming event rates of 8% versus 19% in favour of urgent ERCP.

Results

A total of 304 patients (mean age 55.58±14.10 years; 218 men) were randomised, with 152 assigned to urgent ERCP and 152 to early ERCP. Baseline characteristics were similar between the two groups. There was no significant difference in 30-day mortality between the urgent and early ERCP groups (3.95% vs 6.58%; hazard ratio 0.70, 95% CI 0.25 to 1.93; p=0.47). Likewise, there were no significant differences in in-hospital mortality (1.97% vs 3.28%; relative risk (RR) 1.67, 95% CI 0.40 to 7.20), organ failure at day 3 (9.2% vs 11.2%; RR 1.24, 95% CI 0.59 to 2.62), organ failure at day 30 (11.8% vs 17.1%; RR 1.54, 95% CI 0.80 to 2.94), reintervention rates or readmission rates. The median length of hospital stay was also similar between the groups (6.94 days vs 7.84 days). However, post-ERCP adverse events were more frequent in the urgent ERCP group than in the early ERCP group (17.1% vs 9.2%; RR 2.03, 95% CI 1.02 to 4.07) in the unadjusted analysis.

Conclusion

In patients with mild-to-moderate acute cholangitis, urgent ERCP within 24 hours was not superior to early ERCP within 24–48 hours with respect to mortality or organ failure and is associated with a higher rate of procedure-related adverse events.

Trial registration number

NCT05920954.