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 diagn ostic ERCP. One hundred patients were randomized to two groups of 50 p atients each. Patients in group 1 received an intravenous infusion of 2 g cefotaxime 15 minutes before endoscopy; patients in group 2 did no t 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 ca ses, Peptostreptococcus in 1, and Staphylococcus aureus in 1). Cholang itis or sepsis did not occur after the bacteremic episodes in any of t hese patients. In 4 other patients who did not receive cefotaxime-all of whom had biliary obstruction-clinical cholangitis or sepsis develop ed during the 3-day follow-up; ERCP had failed to decompress the bilia ry system completely in these 4 cases. Blood cultures identified bacte ria 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 suc h episode was observed in patients who had received prophylactic treat ment (chi(2) = 8.7; p < 0.01). The present results indicate that proph ylactic administration of an antibiotic such as cefotaxime can reduce the incidence of bacteremia and sepsis in patients who undergo therape utic or complicated diagnostic ERCP. The risk of septic complication i s mainly related to underlying biliary obstruction. ERCP itself poses only a minor risk for cholangitic and septic complications, even when associated with interventional procedures. Therefore, antibiotic proph ylaxis before ERCP should be limited to cases of pre-existing obstruct ive bile duct disease; it is particularly important after failure of e ndoscopic decompression.