1. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial.
- Author
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Colán-Hernández J, Sendino O, Loras C, Pardo A, Gornals JB, Concepción M, Sánchez-Montes C, Murzi M, Andujar X, Velasquez-Rodriguez J, Rodriguez de Miguel C, Fernández-Esparrach G, Ginés A, and Guarner-Argente C
- Subjects
- Aged, Ciprofloxacin administration & dosage, Female, Humans, Incidence, Male, Middle Aged, Pancreas diagnostic imaging, Pancreas pathology, Pancreatic Cyst pathology, Placebos administration & dosage, Postoperative Complications epidemiology, Postoperative Complications microbiology, Practice Guidelines as Topic, Preoperative Care methods, Spain, Anti-Bacterial Agents administration & dosage, Antibiotic Prophylaxis standards, Endoscopic Ultrasound-Guided Fine Needle Aspiration adverse effects, Pancreatic Cyst diagnosis, Postoperative Complications prevention & control, Preoperative Care standards
- 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)., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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