Original Article

Prophylaxis with Ertapenem in Patients with Obstructive Jaundice Undergoing Endoscopic Retrograde Cholangiopancreatography: Safety, Efficacy, and Biliary Penetration

Authors: Ala I. Sharara, MD, Ihab I. El Hajj, MD, Mohammad Mroueh, PhD, Soula Boustany Kyriacos, PhD, Heitham Abdul-Baki, MD, Hani F. Chaar, PharmD, Elie Aoun, MD, Jana G. Hashash, MD, Nabil M. Mansour, MD, Souha S. Kanj, MD

Abstract

Background: Cholangitis and biliary sepsis are rare but serious complications of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study is to investigate the safety, efficacy, and biliary penetration of ertapenem, a newer carbapenem with a long half-life and broad-spectrum antimicrobial activity, for ERCP prophylaxis.


Methods: Patients with obstructive jaundice without cholangitis received a single dose of ertapenem equal to 1 gram intravenously prior to ERCP. A 2–3 mL bile sample was collected after cannulation and prior to contrast injection. Patients were observed for 72 hours for cholangitis or drug-related adverse events. Biliary ertapenem levels were measured using high-performance liquid chromatography (HPLC).


Results: Twenty-eight patients (ages 18–87 years, M/F ratio 1:1) were enrolled. Seven had no cholestasis and were included to study ertapenem penetration in unobstructed biliary trees. Cannulation was achieved in all patients. One patient (3.6%) with persistent intrahepatic stones developed cholangitis. No drug-related adverse events were noted. The mean time from ertapenem administration to bile collection was 60 ± 24 minutes. There was a significant negative correlation between serum bilirubin and biliary ertapenem levels (r = −0.542, P = 0.003) with the highest level (6.25 μg/mL) noted in unobstructed biliary systems.


Conclusion: Ertapenem appears to be a safe and effective prophylaxis in patients with obstructive jaundice undergoing ERCP despite a limited biliary penetration in patients with high-grade obstruction.


Key Points


* Some studies have suggested that antibiotic prophylaxis does not substantially reduce the incidence of sepsis or cholangitis associated with endoscopic retrograde cholangiopancreatography (ERCP), because the best prevention of post-ERCP cholangitis is complete biliary drainage, which may only occur at highly-experienced centers.


* Ertapenem is a newer carbapenem with a broad antibacterial spectrum, which includes being the most active agent tested against members of the family Enterobacteriaceae, compared to imipenem, cefepime, ceftriaxone, and piperacillin-tazobactam.


* Ertapenem has a long half-life, and may have a combined advantage of preventing the development of bacteremia for many hours following ERCP as well as gradually increasing penetration into the biliary system after decompression.


* In our study, we found ertapenem to be a safe and effective antibiotic prophylaxis in patients with obstructive jaundice, who were undergoing ERCP despite a limited biliary penetration. Ertapenem may also be useful as a possible monotherapy for patients presenting bacterial cholangitis.

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