An Open-Label Trial of Prophylaxis with Ertapenem in Patients with Obstructive Jaundice Undergoing Ercp: Safety, Efficacy, and Biliary Penetration of Ertapenem

Purpose: Antibiotic prophylaxis is recommended for patients with obstructive jaundice undergoing ERCP. Few prospective studies have addressed the efficacy of specific antimicrobial agents in this particular setting or their first-order kinetics and penetration into bile. Ertapenem is a 1-beta-methyl carbapenem with a long-half life and broad-spectrum activity, making it a plausible choice for such prophylaxis. Methods: Patients without evidence of cholangitis scheduled for diagnostic or therapeutic ERCP for evaluation of obstructive jaundice were included. Patients received a single dose of ertapenem 1 gram intravenously on call to ERCP. A 2–3 mL sample of bile was collected at the time of biliary cannulation prior to contrast injection. The time interval from the administration of ertapenem to bile collection was noted. Bile was stored at −70°C and ertapenem levels measured using HPLC. Patients were observed for up to 72 hours post-ERCP for any evidence of cholangitis or possible drug-related adverse events. Results: A total of 28 patients (ages 16–87 years, M/F 1:1) were enrolled after informed consent. Successful biliary cannulation was achieved in all. One patient (3.6%) developed post-ERCP cholangitis despite single-dose ertapenem prophylaxis (patient had cystic dilatation of the right hepatic duct and intrahepatic stones that could not be cleared). No drug-related adverse events were noted. The mean time from administration of ertapenem to bile collection was 60 ± 24 minutes. There was a significant negative correlation between serum bilirubin level and ertapenem level in bile (r = −0.542, P= 0.003). A high-grade obstruction of the biliary tree correlated closely with high levels of serum bilirubin and very low levels of ertapenem (less than 0.1 microg/mL) in bile. The highest levels of ertapenem in bile (up to 6.25 microg/mL) were seen in patients with partial or transient biliary obstruction secondary to common bile duct stones. Conclusion: Ertapenem is a safe and effective agent for prophylaxis in patients with obstructive jaundice undergoing ERCP despite a limited biliary penetration