RESEARCH QUESTION Is a very short-course of antibiotic therapy (ABT) sufficient in patients with acute cholangitis who received adequate source control via endoscopic retrograde cholangiopancreatography (ERCP)?
HYPOTHESIS ABT for 1 day is non-inferior to antibiotic therapy for 4 to 7 days.
STUDY DESIGN Multicenter non-inferiority randomized controlled trial.
STUDY POPULATION Patients with acute cholangitis planned for ERCP will be eligible for inclusion. Patients with acute cholangitis due to common bile duct stones, benign or malignant distal biliary obstruction, or distal biliary stent dysfunction are eligible for inclusion. Exclusion criteria: other etiologies of acute cholangitis, recurrent episode of cholangitis, concomitant cholecystitis or liver abscess, additional infectious diagnosis, use of maintenance ABT, and neutropenia. Inclusion will take place before ERCP, and randomization will take place directly after the ERCP, once adequate source control is achieved.
INTERVENTION The experimental group will receive 1 day of ABT after ERCP and the control group 4 days, with a maximum of 7 days in case of bacteremia. Randomization will be stratified for the blood culture result and underlying etiology.
OUTCOME MEASURES The primary end point is clinical cure by day 14 after ERCP without relapse by day 30. Clinical cure is defined as the absence of both fever and/or shaking chills, and initial presenting symptoms. Relapse is defined as the initiation of new ABT for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.
SAMPLE SIZE/DATA ANALYSIS Assuming a 1-sided 5% alpha, clinical cure rate of 90%, non-inferiority margin of 7.5%, power of 80%, and 10% drop out, 440 patients in total are needed. The primary analysis will compare the clinical cure rate in each group and will be performed as intention-to-treat.