Abstract
Aims International guidelines recommend 4 to 7 days of antibiotic treatment after adequate biliary drainage for acute cholangitis [ 1 ]. Observational data suggest shorter treatment may be sufficient [ 2 ]. We assessed whether 1 day of antibiotic treatment is non-inferior to 4 to 7 days of antibiotic treatment after adequate endoscopic biliary drainage in adults with acute cholangitis. Methods This multicentre, open-label, randomized controlled non-inferiority trial was conducted across 31 hospitals in the Netherlands. We enrolled adults with acute cholangitis (according to Tokyo Guidelines 2018 criteria) due to distal biliary obstruction who achieved adequate endoscopic biliary drainage and fever resolution within 24 hours after ERCP. Patients were randomly assigned 1:1 to receive antibiotics for 1 or 4-7 day(s) after ERCP, stratified by blood culture status and cholangitis aetiology (benign or malignant obstruction) at the time of randomization. We excluded patients with concomitant infections or receiving immunosuppressive therapy. The primary endpoint was clinical cure, defined as the patient being symptom-free by day 14, without relapse or death occurring by day 30. The primary endpoint was adjudicated by an independent blinded committee. We analysed the intention-to-treat and per-protocol population and calculated the absolute risk difference for clinical cure. Non-inferiority was demonstrated if the one-sided 95% confidence limit for the absolute risk difference was greater than -7.5%. Results Between 2023 and 2025, we randomized 413 patients (1-day group: n=205; 4-7-day group: n=208). Median age was 74 years, 43.4% were women, 10.0% had malignant obstruction, 57.6% had moderate/severe cholangitis, and 35.6% had gram-negative bacteraemia at the time of randomization. Adherence to the allocated antibiotic treatment duration was 93.0%. Three patients (all in the 4–7-day group) were lost to follow-up before the primary outcome could be assessed and were excluded from all analyses. In the intention-to-treat analysis, the primary outcome clinical cure occurred in 195/205 patients (95.1%) in the 1-day group versus 192/205 (93.7%) in the 4-7-day group, with an absolute risk difference of 1.5% (one-sided 95% confidence limit: -2.4%), demonstrating non-inferiority. Per-protocol analysis (n=384) showed non-inferiority (absolute risk difference 0.6%, with one-sided 95% confidence limit: -3.2%). In a worst-case sensitivity analysis (with lost to follow-up counting as failures), non-inferiority was maintained. All-cause 30-day mortality was 2/205 in the 1-day group versus 1/205 in the 4-7-day group. Conclusions One day of antibiotic treatment after adequate endoscopic biliary drainage is non-inferior to 4 to 7 days in adults with acute cholangitis. Therefore, 1 day should be the preferred duration of antibiotic treatment after adequate biliary drainage. Publication History Article published online: 05 June 2026 © 2026. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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