Prophylactic antibiotic treatment in therapeutic or complicated diagnostic ERCP: results of a randomized controlled clinical study.

The present study evaluated the effects of prophylactic administration of cefotaxime in patients undergoing therapeutic or complicated diagnostic ERCP. One hundred patients were randomized to two groups of 50 patients each. Patients in group 1 received an intravenous infusion of 2 g cefotaxime 15 minutes before endoscopy; patients in group 2 did not receive an intravenous antibiotic before ERCP (control group). Blood samples were drawn for bacteriologic cultures before endoscopy and 5, 15, 30, and 120 minutes after beginning the procedure. Bacteremia was detected by blood cultures (15- and 30-minute samples) in 4 patients who did not receive prophylactic antibiotics (Escherichia coli in 2 cases, Peptostreptococcus in 1, and Staphylococcus aureus in 1). Cholangitis or sepsis did not occur after the bacteremic episodes in any of these patients. In 4 other patients who did not receive cefotaxime-all of whom had biliary obstruction-clinical cholangitis or sepsis developed during the 3-day follow-up; ERCP had failed to decompress the biliary system completely in these 4 cases. Blood cultures identified bacteria in 3 of these 4 patients (Pseudomonas aeruginosa in 1, E. coli in 2). Thus, bacteremia or clinical sepsis developed in 8/50 patients (16%) in the control group without antibiotic prophylaxis, whereas no such episode was observed in patients who had received prophylactic treatment (chi 2 = 8.7; p < 0.01). The present results indicate that prophylactic administration of an antibiotic such as cefotaxime can reduce the incidence of bacteremia and sepsis in patients who undergo therapeutic or complicated diagnostic ERCP.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes