Urgent versus early ERCP in mild-to-moderate acute cholangitis: a randomised controlled trial

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.