In:
American Journal of Gastroenterology, Ovid Technologies (Wolters Kluwer Health), ( 2023-09-15)
Abstract:
The incidence of post ERCP infections is reported to be up to 18% in patients with biliary obstruction. Antibiotic prophylaxis may reduce the risk of infectious complications after ERCP; however, the clinical value of prophylactic antibiotics in ERCP remains controversial. Methods: We conducted a double-blind, placebo-controlled, randomized trial to investigate whether the use of prophylactic antibiotics would reduce infectious complications after ERCP in patients with biliary obstruction. We randomly assigned patients in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin or normal saline as a placebo 30 min before undergoing ERCP. The primary outcome was the incidence of infectious complications after ERCP. Results: We enrolled 378 patients, and 189 patients were assigned to each group. The risk of infectious complications after ERCP was 2.8% (5 of 176 patients) in the antibiotic-prophylaxis group and 9.8% (17 of 173 patients) in the placebo group (risk ratio, 0.29; 95% confidence interval [CI], 0.11 to 0.74, P =0.0073). The incidence rates of bacteremia were 2.3% (4 of 176 patients) and 6.4% (11 of 173 patients), respectively (risk ratio, 0.36; 95% CI, 0.12 to 1.04; P =0.0599). The incidence rate of cholangitis was 1.7% (3 of 176 patients) in the antibiotic-prophylaxis group and 6.4% (11 of 173 patients) in the placebo group (risk ratio, 0.27; 95% CI, 0.08 to 0.87; P =0.0267). Conclusions: Antibiotic prophylaxis before ERCP in patients with biliary obstruction resulted in a significantly lower risk of infectious complications, especially cholangitis, than placebo (ClinicalTrials.gov trial number NCT02958059).
Type of Medium:
Online Resource
ISSN:
0002-9270
,
1572-0241
DOI:
10.14309/ajg.0000000000002495
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2023
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