Trials / Unknown
UnknownNCT02958059
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Biliary Obstructive Disease Such as Choledocholithiasis
- Benign Biliary Stricture
- Peri-ampullary Cancer
- Bile Duct Cancer Resectable
- Klatskin Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BIOLOGICAL | Placebo | 10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2020-08-01
- Completion
- 2020-08-01
- First posted
- 2016-11-08
- Last updated
- 2019-01-16
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02958059. Inclusion in this directory is not an endorsement.