Background: Cholangitis does not often occur after endoscopic retrograde cholangiopancreatography (ERCP), but it can be a serious complication of this procedure. Antibiotic prophylaxis is therefore frequently used in patients having ERCP, but existing data are insufficient to allow evaluation of the effectiveness of this practice.
Objective: To determine the efficacy of single-dose antibiotic prophylaxis with piperacillin for ERCP-induced cholangitis.
Design: Randomized, double-blind, placebo-controlled clinical trial.
Setting: Tertiary referral center for ERCP.
Patients: Patients who had ERCP for suspected biliary tract stones or distal common bile duct stricture were eligible. Major exclusion 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 placebo was given intravenously approximately 30 minutes before ERCP.
Measurements: Duration of follow-up was 1 week. Acute cholangitis was diagnosed if a patient had a body temperature greater than 38 °C, a clinically apparent need for antibiotic treatment, and no symptoms indicating infection outside of the biliary tree.
Results: 551 consecutive patients were enrolled. During ERCP, stones were found in 147 patients, malignant distal strictures were found in 203 patients, other pathologic findings were seen in 88 patients, and normal biliary tracts were seen in 113 patients. Seventeen of the 281 patients who received placebo (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 cases of cholangitis (with the exception of one case seen in a patient in the piperacillin group) were mild or moderate in severity.
Conclusion: 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 distal common bile duct stricture.