Prophylaxis with ertapenem in patients with obstructive jaundice undergoing endoscopic retrograde cholangiopancreatography: safety, efficacy, and biliary penetration

South Med J. 2011 Mar;104(3):189-94. doi: 10.1097/SMJ.0b013e318205de10.

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / pharmacokinetics
  • Anti-Bacterial Agents / therapeutic use*
  • Antibiotic Prophylaxis*
  • Biliary Tract / metabolism
  • Cholangiopancreatography, Endoscopic Retrograde / adverse effects*
  • Cholangitis / etiology
  • Cholangitis / prevention & control
  • Ertapenem
  • Female
  • Humans
  • Jaundice, Obstructive / diagnosis
  • Jaundice, Obstructive / etiology
  • Jaundice, Obstructive / therapy*
  • Male
  • Middle Aged
  • Sepsis / etiology
  • Sepsis / prevention & control
  • Young Adult
  • beta-Lactams / pharmacokinetics
  • beta-Lactams / therapeutic use*

Substances

  • Anti-Bacterial Agents
  • beta-Lactams
  • Ertapenem