ANTIBIOTIC PROPHYLAXIS NOT REQUIRED FOR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION OF PANCREATIC CYSTIC LESIONS, BASED ON A RANDOMIZED TRIAL

Abstract Background and aims Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether the performing procedure without antimicrobial prophylaxis increases the incidence of infection. Methods We performed a multicenter, randomized, non-inferiority 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. Two-hundred and five 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 groups was 0.87% (95% CI, –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 risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. Clinical Trials.gov number, NCT02261896