Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality. Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected. In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
400
1\~2g of Cefoxitin (2nd generation cephalosporin) is administered to patients 30 minutes Before ERCP procedure. Cefoxitin is mixed with 10ml of normal saline. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
Yonsei university of medical center
Seoul, South Korea
RECRUITINGRate of complication that related with infection.
Time frame: within 10 days
Rate of post-ERCP cholangitis
Time frame: within 10 days
Grade of post-ERCP infectious complication
Grade of post-ERCP infectious complications based upon a consensus definition Mild : \>38°C for 24-48 hr / Moderate : Febrile or septic illness requiring more than 3 days of hospital treatment or endoscopic or percutaneous intervention / Severe : Septic shock or surgery
Time frame: within 10 days
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