Benign Biliary Stricture, Bile Duct Cancer Resectable, Biliary Obstructive Disease Such as Choledocholithiasis, Klatskin Tumor, Peri-ampullary Cancer
Conditions
Keywords
ERCP, prophylaxis, antibiotics, infection, cholangitis
Brief summary
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.
Interventions
BIOLOGICALPacetin® (cefoxitin)
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.
BIOLOGICALPlacebo
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biliary obstructive disease (Benign or Malignant) * 19 year-old and older than 19 year-old
Exclusion criteria
* Younger than 19 year-old * Patients with leukocytosis (WBC ≥ 11,000/mm3) * Body temperature ≥ 38 °C within 72 hours before ERCP * History of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ERCP * Pregnancy women * Patients with allergy to beta-lactam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complication that related with infection. | within 10 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-ERCP cholangitis | within 10 days | — |
| Grade of post-ERCP infectious complication | within 10 days | 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 |
Countries
South Korea
Contacts
Primary ContactSeung Min Bang, MD
Outcome results
None listed