ANTIBIOTIC-PROPHYLAXIS FOR ERCP - A RANDOMIZED CLINICAL-TRIAL COMPARING CIPROFLOXACIN AND CEFUROXIME IN 200 PATIENTS AT HIGH-RISK OF CHOLANGITIS

Objective: To compare the efficacy and safety of oral ciprofloxacin an d intravenous cefuroxime in patients at high risk of cholangitis after endoscopic retrograde cholangiopancreatography (ERCP). Design: Prospe ctive, randomized study. Setting: A primary and tertiary referral cent re. Patients: A series of 232 consecutive patients who either had radi ological evidence of biliary obstruction or were aged over 70 years we re randomly assigned to receive either oral ciprofloxacin or intraveno us cefuroxime before and after ERCP. Two-hundred and nine patients fin ished the study, with 23 being excluded because of withdrawal of conse nt or incomplete ERCP. Interventions: Patients underwent ERCP; blood s amples were taken for culture, full blood count and biochemistry befor e and after the procedure. Clinical follow-up was carried out 7 and 42 days after ERCP. Main outcome measures: Clinical, bacteriological or biochemical evidence of cholangitis, septicaemia or adverse drug react ions, and the cost of both protocols. Results: Follow-up was recorded in all 209 patients who completed the study. By 42 days after ERCP, th ree patients had died (cholangiocancer, pancreatic cancer and renal fa ilure). Cholangitis was diagnosed in one patient from each of the two trial groups. Blood cultures from the patient on ciprofloxacin gave ne gative results, but a post-ERCP blood sample from the patient on cefur oxime grew Pseudomonas aeruginosa, which was sensitive to ciprofloxaci n. There were no serious side-effects in either study group, but two p atients assigned to ciprofloxacin became too nauseous to take the medi cation. The cost of the cefuroxime protocol was pound 7.56 per patient , compared with pound 4.76 per patient for the ciprofloxacin protocol. Conclusion: A pre- and post-ERCP oral ciprofloxacin regime is safe an d provides effective prophylaxis against ERCP-induced cholangitis and septicaemia in high-risk patients. It is also more economical than a r egime of intravenous cefuroxime and does not require nursing staff wit h training in intravenous techniques.