Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
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|ClinicalTrials.gov Identifier: NCT02958059|
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : January 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Obstructive Disease Such as Choledocholithiasis Benign Biliary Stricture Peri-ampullary Cancer Bile Duct Cancer Resectable Klatskin Tumor||Biological: Pacetin® (cefoxitin) Biological: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
The intervention group
Biological: Pacetin® (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.
Other Name: Antibiotic prophylaxis
Placebo Comparator: Comparator
The comparator group
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
Other Name: normal saline
- Rate 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958059
|Contact: Seung Min Bang, MD||+82-02-2228-1995||BANG7028@yuhs.ac|
|Korea, Republic of|
|Yonsei university of medical center||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Seung Min Bang, MD +82 2 2228 1995 BANG7028@yuhs.ac|