Cholangitis and pancreatitis are severe complications of endoscopic retrogr
ade cholangiopancreatography, (ERCP). Antibiotics have been considered impo
rtant in preventing cholangitis, especially in those with jaundice. Some ha
ve suggested that bacteria may play a role in the induction of post-ERCP pa
ncreatitis. It is not clear, however, whether the incidence of post-ERCP pa
ncreatitis 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 gr
oup (n = 161) that was given 2 g of cephtazidime intravenously 30 minutes b
efore 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 antib
iotics during the preceding week were included. Patients who were allergic
to cephalosporins, patients with immune deficiency or any other condition r
equiring antibiotic prophylaxis, patients with clinical jaundice, and pregn
ant patients were excluded. In the final analysis six patients were exclude
d because of a diagnosis of bile duct obstruction but with unsuccessful bil
iary drainage that required immediate antibiotic treatment. The diagnosis o
f cholangitis was based on a rising fever, an increase in the C-reactive pr
otein (CRP) level, and increases in leukocyte count and liver function valu
es, which were associated with bacteremia in some. The diagnosis of acute p
ancreatitis was based on clinical findings, and increases in the serum amyl
ase level (> 900 IU/L), CRP level, and leukocyte count with no increase in
liver chemical values. The control group had significantly more patients wi
th 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 prophylaxi
s group (6%) and 15 patients in the control group (9%) had remarkably incre
ased serum amylase levels (> 900 IU/L) after ERCP, but clinical signs of ac
ute pancreatitis with leukocytosis, CRP reaction, and pain developed in fou
r of nine patients in the prophylaxis group compared to 15 of 15 patients w
ith hyperamylasemia in the control group (P = 0.003). In a multivariate ana
lysis, the lack of antibiotic prophylaxis (odds ratio 6.63, P = 0.03) and s
phincterotomy (odds ratio 5.60, P = 0.05) were independent risk factors for
the development of post-ERCP pancreatitis. We conclude that antibiotic pro
phylaxis effectively decreases the risk of pancreatitis, in addition to cho
langitis after ERCP, and can thus be routinely recommended prior to ERCP Th
ese results suggest that bacteria could play a role in the pathogenesis of
post-ERCP pancreatitis.