PIPERACILLIN TO PREVENT CHOLANGITIS AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY - A RANDOMIZED, CONTROLLED TRIAL

Background: Cholangitis does not often occur after endoscopic retrogra de cholangiopancreatography (ERCP), but it can be a serious complicati on of this procedure. Antibiotic prophylaxis is therefore frequently u sed in patients having ERCP, but existing data are insufficient to all ow evaluation of the effectiveness of this practice. Objective: To det ermine the efficacy of single-dose antibiotic prophylaxis with piperac illin for ERCP-induced cholangitis. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Tertiary referral center f or ERCP. Patients: Patients who had ERCP for suspected biliary tract s tones or distal common bile duct stricture were eligible. Major exclus ion criteria were previous ERCP within 7 days, biliary endoprosthesis in situ, and use of antimicrobial agents or presence of fever within 7 days before the procedure. Intervention: Piperacillin, 4 g, or placeb o was given intravenously approximately 30 minutes before ERCP. Measur ements: Duration of follow-up was 1 week. Acute cholangitis was diagno sed if a patient had a body temperature greater than 38 degrees C, a c linically apparent need for antibiotic treatment, and no symptoms indi cating infection outside of the biliary tree. Results: 551 consecutive patients were enrolled. During ERCP, stones were found in 147 patient s, malignant distal strictures were found in 203 patients, other patho logic findings were seen in 88 patients, and normal biliary tracts wer e seen in 113 patients. Seventeen of the 281 patients who received pla cebo (6.0%) and 12 of the 270 patients who received piperacillin (4.4% ) developed acute cholangitis (relative risk, 0.73 [95% CI, 0.36 to 1. 51]). The absolute risk reduction was 1.6% (CI, -5.3% to 2.1%). All ca ses of cholangitis (with the exception of one case seen in a patient i n the piperacillin group) were mild or moderate in severity. Conclusio n: Single-dose prophylaxis with piperacillin is not associated with a clinically significant reduction in the incidence of acute cholangitis after ERCP in patients suspected of having biliary tract stones or di stal common bile duct stricture.