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Randomized Controlled Trial
. 2024 Jan 1;119(1):183-190.
doi: 10.14309/ajg.0000000000002495. Epub 2023 Sep 15.

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

Galam Leem  1   2 , Min Je Sung  3 , Ji Hoon Park  4 , So Jeong Kim  5 , Jung Hyun Jo  1   2 , Hee Seung Lee  1   2 , Nam Su Ku  6 , Jeong Youp Park  1   2 , Seungmin Bang  1   2 , Seung Woo Park  1   2 , Si Young Song  1   2 , Moon Jae Chung  1   2
Affiliations
Randomized Controlled Trial

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

Galam Leem et al. Am J Gastroenterol. .

Abstract

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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Conflict of interest statement

Gaurantor of article: Moon Jae Chung, MD, PhD.

Specific author contributions: G.L., M.J.S., J.H.P., S.J.K., J.H.J., H.S.L., N.S.K., J.Y.P., S.B., S.W.P., S.Y.S., M.J.C.: conception and design. G.L., M.J.S., J.H.P., S.J.K., J.H.J., H.S.L., J.Y.P., S.B., M.J.C.: administrative support. G.L., M.J.S., J.H.P., S.J.K., J.H.J., H.S.L., J.Y.P., S.B., M.J.C.: provision of patients. G.L., M.J.S., J.H.P.: collection and assembly of data. G.L., M.J.S., J.H.P.: data analysis and interpretation. All authors: manuscript writing. All authors: Final approval of manuscript.

Financial support: The antibiotic used in this trial (Pacetin) was provided by JW Pharmaceutical, Seoul, Korea. No other funding sources were available.

Potential competing interests: The antibiotic used in this trial (Pacetin) was provided by JW Pharmaceutical, Seoul, Korea. However, this trial was designed and conducted independently of JW Pharmaceutical, and the authors declare no conflicts of interest.

Ethics approval and consent to participate: This study was approved by the Institutional Review Board of the Yonsei University Medical Center (number 4-2015-0596). All patients gave their written informed consent.

Data sharing: The trial protocol and deidentified participant data collected for this trial are available from the corresponding author M.J.C. on reasonable request.

Figures

Figure 1.
Figure 1.
Trial profile. Summarized flow of enrollment, randomization, follow-up, and outcomes. ERCP, endoscopic retrograde cholangiopancreatography.
Figure 2.
Figure 2.
Risk factor analysis for post-ERCP infectious complications. In the placebo group, clinical factors and procedure-related factors were included in the analysis. BD, bile duct; ERCP, endoscopic retrograde cholangiopancreatography; PA, peri-ampullary.
See this image and copyright information in PMC

References

    1. Canakis A, Baron TH. Relief of biliary obstruction: Choosing between endoscopic ultrasound and endoscopic retrograde cholangiopancreatography. BMJ Open Gastroenterol 2020;7(1):e000428. - PMC - PubMed
    1. Andriulli A, Loperfido S, Napolitano G, et al. Incidence rates of post-ERCP complications: A systematic survey of prospective studies. Am J Gastroenterol 2007;102:1781–8. - PubMed
    1. Williams E, Taylor S, Fairclough P, et al. Risk factors for complication following ERCP; results of a large−scale, prospective multicenter study. Endoscopy 2007;39(09):793–801. - PubMed
    1. Cotton PB, Connor P, Rawls E, et al. Infection after ERCP, and antibiotic prophylaxis: A sequential quality-improvement approach over 11 years. Gastrointest Endosc 2008;67(3):471–5. - PubMed
    1. Chandrasekhara V, Khashab MA, Muthusamy VR, et al. Adverse events associated with ERCP. Gastrointest Endosc 2017;85(1):32–47. - PubMed

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