Abstract

The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. This study compared the occurrence rate of post-procedural complications, including cholangitis and septicemia, between prophylactic intravenous moxifloxacin and ceftriaxone in patients with bile duct obstruction scheduled for therapeutic ERCP. From November 2013 to July 2015, 86 consecutive patients with biliary obstruction with one or more factors predicting benefits of antibiotic prophylaxis prior to ERCP were included in the current randomized open-label non-inferiority trial (ClinicalTrial.gov identifier NCT02098486). Intravenous moxifloxacin (400 mg/day) or ceftriaxone (2 g/day) were given 90 minutes before ERCP, and were administered for more than 3 days if the patient developed symptoms and signs of cholangitis or septicemia. Recalcitrant cholangitis was defined as persistence of cholangitis for more than 5 days after ERCP or recurrence of cholangitis within 30 days after ERCP. Recalcitrant cholangitis occurred in 1 (2.3%) and 2 (4.8%) patients receiving intravenous moxifloxacin and ceftriaxone group, respectively (P=0.612). Septicemia was noted in 1 (2.3%) and 1 (2.4%) patient in intravenous moxifloxacin and ceftriaxone group, respectively (P=1.0). The mean hospital stay was also not significantly different between the moxifloxacin and ceftriaxone groups (8.8±7.2 vs 9.1±9.4 days, P=0.867). Antibiotic resistance of the isolated pathogens by in vitro activity assay was noted in 1 (2.3%) and 2 (4.8%) patients in the moxifloxacin and ceftriaxone group, respectively (P=0.612). Intravenous moxifloxacin is not inferior to intravenous ceftriaxone for the prophylactic treatment of post-ERCP cholangitis and cholangitis-associated morbidity.

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