[Comparative studies of preventive antibiotic administration in ERCP].

In a nonblind nonrandomized clinical trial two groups of patients who were undergoing ERCP - A (n = 182) with antibiotic prophylaxis and B (n = 220) without an antibiotic--were compared on a prospective basis. The efficacy of properly timed prophylaxis with a therapeutically effective antibiotic had previously been established by a pilot study and a definitive trial based on HPLC assays of endoscopic biopsy specimens taken from the duodenal papilla. In Group A (n = 182) there was hyperamylasaemia without a leucocytic reaction in only 18 (14.75%) of the ERP patients and two (3.33%) of the ERC patients, but in Group B (no antibiotic - n = 220) this change was detected in 48 (35.29%) of the ERP patients and 12 (14.28%) of the ERC patients (P = 0.00018 and 0.043 respectively). Hyperamylasaemia with a leucocytic reaction occurred in only one patient with ERP from Group A (0.82%) as compared with 15 patients (11.02%) from the untreated group (P = 0.00047). These results were highly significant. There were three cases of subclinical pancreatitis and two of acute pancreatitis--all of them in the control group. Although these results were not statistically significant (because the number of cases was too small), they are clearly consistent with the growing tendency towards using antibiotic cover. On the basis of these results we regard antibiotic prophylaxis during ERCP as a sensible precaution, and in patients with any concurrent disease which heightens the risk it is essential.