Am J Gastroenterol. 2023 Sep 15. doi: 10.14309/ajg.0000000000002495. Online ahead of print.
ABSTRACT
BACKGROUND: 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).
PMID:37713527 | DOI:10.14309/ajg.0000000000002495