Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial

Gastroenterology. 2020 May;158(6):1642-1649.e1. doi: 10.1053/j.gastro.2020.01.025. Epub 2020 Jan 20.

Abstract

Background & aims: Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection.

Methods: We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events.

Results: The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, -0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events.

Conclusions: In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).

Keywords: Direct Comparison; Fluid Collection; Outcome; Risk Factor.

Publication types

  • Clinical Trial, Phase IV
  • Equivalence Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anti-Bacterial Agents / administration & dosage*
  • Antibiotic Prophylaxis / standards*
  • Ciprofloxacin / administration & dosage
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration / adverse effects*
  • Female
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Pancreas / diagnostic imaging
  • Pancreas / pathology
  • Pancreatic Cyst / diagnosis*
  • Pancreatic Cyst / pathology
  • Placebos / administration & dosage
  • Postoperative Complications / epidemiology
  • Postoperative Complications / microbiology
  • Postoperative Complications / prevention & control*
  • Practice Guidelines as Topic
  • Preoperative Care / methods
  • Preoperative Care / standards*
  • Spain

Substances

  • Anti-Bacterial Agents
  • Placebos
  • Ciprofloxacin

Associated data

  • ClinicalTrials.gov/NCT02261896