February 03, 2020
By Marilynn Larkin
NEW YORK (Reuters Health) - Although guidelines recommend antibiotic prophylaxis before or during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, the risk of infection from the procedure is low, a randomized controlled trial reveals.
Dr. Carlos Guarner-Argente of Hospital de la Santa Creu i Sant Pau in Barcelona, Spain, said the current study confirms his group's earlier retrospective study that also evaluated antibiotic prophylaxis in patients undergoing EUS-FNA of pancreatic cystic lesions. (http://bit.ly/36W4w9f) That study "slightly changed U.S. clinical guidelines for antibiotic prophylaxis, from 'recommended' to 'suggested,'" he told Reuters Health by email.
"In the current clinical trial, we confirmed a very low (incidence of) infection for this procedure, which we believe will change clinical guidelines recommendations and, subsequently, impact clinical practice," he said.
"It is important to highlight that the study did not include mediastinal and foregut cysts, which might have a higher risk of infection," he noted. "Additionally, the number of patients on immunosuppressive therapy or with conditions such as HIV was very low in the trial, so antibiotic prophylaxis in these patients should be individually considered, or they should be closely followed after the procedure."
In his team's multicenter non-inferiority trial, 226 patients (mean age, 64; about half, women) with a pancreatic cyst requiring EUS-FNA were randomly assigned to ciprofloxacin (one 200-mg IV bolus followed by 500-mg orally every 12 hours for seven doses) or saline solution plus dummy pills, and were followed for 21 days.
There were no statistically significant between-group differences in demographics, baseline data, or procedure characteristics.
As reported in Gastroenterology, 205 patients (90.7%) completed the trial. The only case of FNA-related infection occurred in a patient in the placebo group who developed acute pancreatitis and bacteremia after the procedure.
Notably, prevention of infection was not inferior in the control group; the between-group difference was 0.87%. Further, there were no between-group differences in fever (two patients in each group; 1.78% vs. 1.76%) or other adverse events.
Dr. Guarner-Argente said, "I would like to emphasize the importance of avoiding an unnecessary medication, especially in the case of antibiotics, due to the possible association with adverse events and bacterial resistance."
Dr. Stephen Heller, Director of Gastrointestinal Endoscopy at Temple University Hospital in Philadelphia, commented by email, "This is a welcome study, well-designed, that fits in with our clinical experience, which reflects a very low rate of infection from FNA of pancreas cysts."
"Avoiding antibiotics in this setting has potential to cut down on antibiotic-related side effects such as C. difficile infection, and reduce costs," he told Reuters Health.
"I would still consider antibiotic prophylaxis in high-risk groups - i.e., patients who are immunosuppressed, such as those receiving chemotherapy or who have undergone organ transplant," he said.
"We still need to be mindful of other potential adverse events from FNA of pancreas cysts, such as bleeding and pancreatitis," he added.
SOURCE: http://bit.ly/2GN4aaq Gastroenterology, online January 20, 2020.
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