Timing of Endoscopic Retrograde Cholangiography for Acute Cholangitis – A Randomized Controlled Trial

Aims The ideal timing of endoscopic retrograde cholangiopancreatography (ERCP) for patients with mild and moderate acute cholangitis remains uncertain. This single-centre randomized controlled trial (RCT) aimed to compare the outcomes of ERCP performed within 24 hours (urgent group) versus ERCP performed between 24 and 48 hours (early group) following hospital admission.

Methods A total of 304 patients with mild to moderate cholangitis, as per the Tokyo guidelines, admitted at the AIG hospitals, Hyderabad, India, from 30th June 2023 to 10th June 2024 were randomized to either the early ERCP group (n=152, mean age (SD): 56.09(13.65) years, 108 men) or the urgent ERCP group (n=152, mean age (SD): 55.07(14.56) years, 110 men). The Primary outcome was 30-day mortality. Secondary outcomes included organ failure on day 3 and day 30, in-hospital mortality, length of hospital stay, re-intervention rates, and post-ERCP complications. Odds ratios (OR) with 95% confidence intervals (CI) and p-values were calculated for binary outcomes, while the Mann-Whitney test was used for continuous data. (ClinicalTrials.gov number, NCT 05920954)

Results There were 113 (74.3%) and 107 (71.1%) patients with moderate acute cholangitis in the urgent and early groups, respectively (p=0.442). There was no significant difference in 30-day mortality between the early and urgent groups (6.6% vs. 3.9%; p=0.304; OR: 0.58, 95% CI: 0.21–1.65). Similarly, rates of in-hospital mortality (3.3% vs. 1.97%; p=0.474; OR: 0.59, 95% CI: 0.14–2.52) and organ failure on day 3 (11.2% vs. 9.2%; p=0.57; OR: 0.81, 95% CI: 0.38–1.70) and day 30 (17.1% vs. 11.8%; p=0.192; OR: 0.65, 95% CI: 0.34–1.25) were comparable between the groups. The median length of hospital stay was similar (6.58 vs. 6.29 days; p=0.364). Re-intervention rates were not significantly different (4.6% vs. 6.6%; p=0.45; OR: 1.46, 95% CI: 0.54–3.94). However, post-ERCP complications were significantly lower in the early group (9.2% vs. 17.1%; p=0.042; OR: 0.49, 95% CI: 0.25–0.98).

Conclusions In patients with mild and moderate cholangitis, early ERCP within 24 hours did not significantly reduce 30-day mortality or organ failure compared to ERCP performed between 24 and 48 hours. However, early ERCP was associated with a significantly lower rate of post-ERCP complications. Early ERCP may reduce procedural complications without affecting mortality outcomes. Further multicenter studies are warranted to validate these results [1] [2] [3].

Publikationsverlauf

Artikel online veröffentlicht:
27. März 2025

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