Randomized Trial of Prophylactic Antibiotics for Endoscopic Retrograde Cholangiopancreatography in Patients With Biliary Obstruction

医学 内镜逆行胰胆管造影术 内科学 抗生素 安慰剂 入射(几何) 随机对照试验 预防性抗生素 置信区间 外科 菌血症 胃肠病学 胰腺炎 物理 病理 光学 替代医学 微生物学 生物
作者
Galam Leem,Min Je Sung,Ji Hoon Park,So Jeong Kim,Jung Hyun Jo,Hee Seung Lee,Nam Su Ku,Jeong Youp Park,Seungmin Bang,Seung Woo Park,Si Young Song,Moon Jae Chung
出处
期刊:The American Journal of Gastroenterology [American College of Gastroenterology]
卷期号:119 (1): 183-190 被引量:17
标识
DOI:10.14309/ajg.0000000000002495
摘要

INTRODUCTION: The incidence of postendoscopic retrograde cholangiopancreatography (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 minutes 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], 0.11–0.74, 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, 0.12–1.04; 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, 0.08–0.87; P = 0.0267). DISCUSSION: 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).
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