Piperacillin to prevent cholangitis after endoscopic retrograde cholangiopancreatography. A randomized, controlled trial. Post-ERCP pancreatitis: reduction by routine antibiotics. Antibiotic prophylaxis of infectious complications with endoscopic retrograde cholangiopancreatography. A randomized controlled study. Prospective assessment of the role of antibiotic prophylaxis in ERCP. Antibiotic prophylaxis for infectious complications after therapeutic endoscopic retrograde cholangiopancreatography: a randomized, double-blind, placebo-controlled study. ERCP: Complications and prophylaxis a controlled study. [Antibiotic prophylaxis using cefuroxime in bile duct endoscopy].
Cholangitis does not often occur after endoscopic retrograde cholangiopancreatography (ERCP), but it can be a serious complication of this procedure. Antibiotic prophylaxis is therefore frequently used in patients having ERCP, but existing data are insufficient to allow evaluation of the effectiveness of this practice.
                To determine the efficacy of single-dose antibiotic prophylaxis with piperacillin for ERCP-induced cholangitis.
                Randomized, double-blind, placebo-controlled clinical trial.
                Tertiary referral center for ERCP.
                Patients who had ERCP for suspected biliary tract stones or distal common bile duct stricture were eligible. Major exclusion criteria were previous ERCP within 7 days, biliary endoprosthesis in situ, and use of antimicrobial agents or presence of fever within 7 days before the procedure.
                Piperacillin, 4 g, or placebo was given intravenously approximately 30 minutes before ERCP.
                Duration of follow-up was 1 week. Acute cholangitis was diagnosed if a patient had a body temperature greater than 38 degrees C, a clinically apparent need for antibiotic treatment, and no symptoms indicating infection outside of the biliary tree.
                551 consecutive patients were enrolled. During ERCP, stones were found in 147 patients, malignant distal strictures were found in 203 patients, other pathologic findings were seen in 88 patients, and normal biliary tracts were seen in 113 patients. Seventeen of the 281 patients who received placebo (6.0%) and 12 of the 270 patients who received piperacillin (4.4%) developed acute cholangitis (relative risk, 0.73 [95% CI, 0.36 to 1.51]). The absolute risk reduction was 1.6% (CI, -5.3% to 2.1%). All cases of cholangitis (with the exception of one case seen in a patient in the piperacillin group) were mild or moderate in severity.
                Single-dose prophylaxis with piperacillin is not associated with a clinically significant reduction in the incidence of acute cholangitis after ERCP in patients suspected of having biliary tract stones or distal common bile duct stricture. Cholangitis and pancreatitis are severe complications of endoscopic retrograde cholangiopancreatography (ERCP). Antibiotics have been considered important in preventing cholangitis, especially in those with jaundice. Some have suggested that bacteria may play a role in the induction of post-ERCP pancreatitis. It is not clear, however, whether the incidence of post-ERCP pancreatitis could be reduced by antibiotic prophylaxis, as is the case with septic complications. In this prospective study, a total of 321 consecutive patients were randomized to the following two groups: (1) a prophylaxis group (n = 161) that was given 2 g of cephtazidime intravenously 30 minutes before ERCP, and (2) a control group (n = 160) that received no antibiotics. All patients admitted to the hospital for ERCP who had not taken any antibiotics during the preceding week were included. Patients who were allergic to cephalosporins, patients with immune deficiency or any other condition requiring antibiotic prophylaxis, patients with clinical jaundice, and pregnant patients were excluded. In the final analysis six patients were excluded because of a diagnosis of bile duct obstruction but with unsuccessful biliary drainage that required immediate antibiotic treatment. The diagnosis of cholangitis was based on a rising fever, an increase in the C-reactive protein (CRP) level, and increases in leukocyte count and liver function values, which were associated with bacteremia in some. The diagnosis of acute pancreatitis was based on clinical findings, and increases in the serum amylase level (>900 IU/L), CRP level, and leukocyte count with no increase in liver chemical values. The control group had significantly more patients with post-ERCP pancreatitis (15 of 160 in the prophylaxis group vs. 4 of 155 in the control group; P = 0.009) and cholangitis (7 of 160 vs. 0 of 155; P = 0.009) compared to the prophylaxis group. Nine patients in the prophylaxis group (6%) and 15 patients in the control group (9%) had remarkably increased serum amylase levels (>900 IU/L) after ERCP, but clinical signs of acute pancreatitis with leukocytosis, CRP reaction, and pain developed in four of nine patients in the prophylaxis group compared to 15 of 15 patients with hyperamylasemia in the control group (P = 0.003). In a multivariate analysis, the lack of antibiotic prophylaxis (odds ratio 6.63, P = 0.03) and sphincterotomy (odds ratio 5.60, P = 0.05) were independent risk factors for the development of post-ERCP pancreatitis. We conclude that antibiotic prophylaxis effectively decreases the risk of pancreatitis, in addition to cholangitis after ERCP, and can thus be routinely recommended prior to ERCP. These results suggest that bacteria could play a role in the pathogenesis of post-ERCP pancreatitis Biliary sepsis represents a major percentage of fatal complications after endoscopic retrograde cholangiopancreatography. We performed a randomized controlled study to investigate the value of antibiotic prophylaxis, and to assess the frequency and source of infectious complications associated with ERCP. Ninety-six patients who underwent 100 endoscopic retrograde cholangiopancreatographies were included in the study. Half of the patients received antibiotic prophylaxis (Cefotaxime 2 g i.v. 15 min before the procedure). Bacteremia was detected in 2% of the patients receiving antibiotic prophylaxis, as compared with 16% (p less than 0.02) in the control group. In order to determine the source of bacteremia, bile samples and irrigation fluid from the suction channel of the endo-scope were obtained for bacteriological evaluation. Several lines of evidence suggested that bacteremia associated with ERCP was essentially caused by mucosal lesions of the oropharynx. Bacteremia was asymptomatic, with the exception of two patients who subsequently developed fever, but recovered rapidly under antibiotic therapy. The frequency of cholangitis following ERCP was not significantly reduced by antibiotic prophylaxis (4% vs. 2%). Recommendations for antibiotic prophylaxis are discussed. Despite the existence of published recommendations, various studies of antibiotic prophylaxis have reached conflicting conclusions, and controversy exists regarding the role of antibiotic prophylaxis in ERCP. The aim of this study was to analyze the efficacy of the intramuscular administration of clindamicine and gentamicine before ERCP.
                Sixty-one consecutive patients referred for ERCP were prospectively randomized to receive either clindamicine 600mg and gentamicine 80mg, both intramuscularly one hour before the ERCP (group I; 31 patients) or not (group II; 30 patients). Two blood samples were obtained from every patient (just before endoscopy and within 5 minutes of withdrawal of the endoscope) and were incubated for 7 days and examined daily for growth of bacteria. Patients were closely monitored for 7 days after endoscopy to detect the development of infectious complications.
                Only 7 cultures from 7 patients were positive. Four were obtained post-ERCP (two patients in group I and two in group II) and the remaining three before endoscopy. The post-ERCP isolated bacteria were: Streptococcus mitis, Peptoestreptococcus anaerobious, Moraxella spp and Escherichia coli. Two patients, one from each group, developed post-ERCP cholangitis that were solved with medical treatment.
                Our findings indicate that ERCP induce bacteremia in a small group of patients and suggest that prophylactic administration of clindamicine plus gentamicine does not reduce the incidence of bacteremia and cholangitis, and do not support the routine use of prophylactic antibiotics prior to ERCP. We performed a randomized, double-blind, placebo-controlled trial of antibiotic prophylaxis before diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in 82 uninfected patients with cholestasis due to biliary tree obstruction of single or multiple causes. The patients were assigned to receive piperacillin (4 g) or placebo three times daily; prophylaxis was started just before initial ERCP and was continued until biliary drainage was completely unobstructed (by one or more ERCP procedures); the maximal duration of prophylaxis was 7 days. Nine patients were withdrawn from the study, and five others could not be assessed because of protocol violations. The 68 clinically evaluable patients underwent 81 therapeutic ERCP procedures. Clinical success (defined as an absence of fever, cholangitis, and clinical signs of sepsis during the 48 hours after the last dose of piperacillin or placebo) was documented for 32 (94%) of the 34 patients given piperacillin and for 24 (71%) of the 34 patients given placebo (odds ratio, 6.66; P = .01). Complete biliary drainage influenced clinical outcome favorably (odds ratio, 5.0; P = .02). All seven instances of bacteriologic failure (bacteremia) involved patients in the placebo group (P < .01). We concluded that antimicrobial prophylaxis significantly reduces the incidence of septic complications after therapeutic ERCP among patients presenting with cholestasis. Prophylactic measures for the prevention of complications (pancreatitis, pancreatic and biliary sepsis) after an ERCP examination were investigated in a controlled study. A total of 118 patients were selected at random and divided into three groups by post-ERCP treatment (Group A: no treatment, Group B: oral prophylaxis with broad spectrum tetracycline, Group C: bedrest for 36 hours, fasting, stomach catheter and infusion prophylaxis. The total rate of complications in the study as a whole was 5% (2.5% pancreatitis, 2.5% bacterial complications). Statistical comparison of the groups produced no significant differences, i.e. neither the antibiotic nor the infusion prophylaxis proved advantageous with respect to the frequency of pancreatitis and bacterial complications. In addition to this, prophylactic measures after ERCP had no influence on the frequency, duration and extent of such temporary symptoms as abdominal discomfort, fever, leukocytosis, hyperamylasemia, hyperamylasuria and cholestasis. It is worth considering carrying out ERCP on an out-patient basis in special cases. To assess prospectively the effectiveness of a single prophylactic dose of cefuroxim before therapeutic endoscopy, in view of the general practice not to give antibiotics routinely.
                In a prospective study endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography with drainage (PTCD) together with simultaneous stone extraction, dilatation or stent implantation were performed in 99 patients (51 men, 48 women; mean age 60.6 +/- 19.2 years). Group A (n = 49) received 1500 mg cefuroxim i.e. 30 min before the procedure, while none was given to group A patients (n = 50). Several blood cultures were taken up to 60 min after the endoscopy. The number of septicaemias (bacteraemia with fever, rigor, circulatory reactions, leukocytosis or leukopenia) were noted. Bile cultures were obtained in 56 patients with indwelling biliary drainage.
                Incidence of bacteraemia was 6.1% (3 of 49) in group A, 16% (8 of 50) in group B, but this difference is not statistically significant. The septicaemia rate was 6.1% in group A and 10% in group B (not significant). There were eleven positive blood cultures with 12 different microorganisms, Escherichia coli in four (A: n = 3). In vitro cefuroxim sensitivity was 53.3%. 25 different bacterial species were isolated from 73.2% of bile cultures, of which 53.4% were sensitive to cefuroxim and 8.2% moderately so.
                Although the obtained differences between the two groups were not statistically different, the reduction in bacteraemia/septicaemia rate may be of clinical use. Further studies are needed with higher dosages or antibiotic combinations to improve these results.