Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient

Study Overview
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Brief Summary
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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.

Conditions
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Klatskin Tumor, Biliary Obstructive Disease Such as Choledocholithiasis, Benign Biliary Stricture, Peri-ampullary Cancer, Bile Duct Cancer Resectable

Intervention / Treatment
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* Biological: Pacetin® (cefoxitin)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The intervention group | Biological: Pacetin® (cefoxitin)<br>* 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.<br>* Other names: Antibiotic prophylaxis;|
| Placebo Comparator: Comparator<br>The comparator group | Biological: Placebo<br>* 10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complication that related with infection. |  | within 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-ERCP cholangitis |  | 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 | within 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, prophylaxis, antibiotics, infection, cholangitis