ANTIBIOTIC-PROPHYLAXIS FOR INFECTIOUS COMPLICATIONS AFTER THERAPEUTICENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

We performed a randomized, double-blind, placebo-controlled trial of a ntibiotic prophylaxis before diagnostic and therapeutic endoscopic ret rograde cholangiopancreatography (ERCP) in 82 uninfected patients with cholestasis due to biliary tree obstruction of single or multiple cau ses. The patients were assigned to receive piperacillin (4 g) or place bo three times daily; prophylaxis was started just before initial ERCP and was continued until biliary drainage was completely unobstructed (by one or more ERCP procedures); the maximal duration of prophylaxis was 7 days, Nine patients were withdrawn from the study, and five othe rs could not be assessed because of protocol violations. The 68 clinic ally evaluable patients underwent 81 therapeutic ERCP procedures. Clin ical success (defined as an absence of fever, cholangitis, and clinica l signs of sepsis during the 48 hours after the last dose of piperacil lin or placebo) was documented for 32 (94%) of the 34 patients given p iperacillin and for 24 (71%) of the 34 patients given placebo (odds ra tio, 6.66; P =.01). Complete biliary drainage influenced clinical outc ome favorably (odds ratio, 5.0; P =.02). All seven instances of bacter iologic failure (bacteremia) involved patients in the placebo group (P <.01). We concluded that antimicrobial prophylaxis significantly redu ces the incidence of septic complications after therapeutic ERCP among patients presenting with cholestasis.