Piperacillin to prevent cholangitis after endoscopic retrograde cholangiopancreatography. A randomized, controlled trial.

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 degrees 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.