Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
Primary Purpose
Biliary Obstructive Disease Such as Choledocholithiasis, Benign Biliary Stricture, Peri-ampullary Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pacetin® (cefoxitin)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Biliary Obstructive Disease Such as Choledocholithiasis focused on measuring ERCP, prophylaxis, antibiotics, infection, cholangitis
Eligibility Criteria
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
Sites / Locations
- Yonsei university of medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Comparator
Arm Description
The intervention group
The comparator group
Outcomes
Primary Outcome Measures
Rate of complication that related with infection.
Secondary Outcome Measures
Rate of post-ERCP cholangitis
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02958059
Brief Title
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Obstructive Disease Such as Choledocholithiasis, Benign Biliary Stricture, Peri-ampullary Cancer, Bile Duct Cancer Resectable, Klatskin Tumor
Keywords
ERCP, prophylaxis, antibiotics, infection, cholangitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The intervention group
Arm Title
Comparator
Arm Type
Placebo Comparator
Arm Description
The comparator group
Intervention Type
Biological
Intervention Name(s)
Pacetin® (cefoxitin)
Other Intervention Name(s)
Antibiotic prophylaxis
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline
Intervention Description
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
Primary Outcome Measure Information:
Title
Rate of complication that related with infection.
Time Frame
within 10 days
Secondary Outcome Measure Information:
Title
Rate of post-ERCP cholangitis
Time Frame
within 10 days
Title
Grade of post-ERCP infectious complication
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Min Bang, MD
Phone
+82-02-2228-1995
Email
BANG7028@yuhs.ac
Facility Information:
Facility Name
Yonsei university of medical center
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Min Bang, MD
Phone
+82 2 2228 1995
Email
BANG7028@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
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