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

Klatskin Tumor Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958059
• Other study ID #: 4-2015-0596
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: August 2020

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Seung Min Bang, MD
• Phone: +82-02-2228-1995
• Email: BANG7028[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Biliary Stricture
• Bile Duct Cancer Resectable
• Bile Duct Neoplasms
• Biliary Obstructive Disease Such as Choledocholithiasis
• Cholangiocarcinoma
• Choledocholithiasis
• Klatskin Tumor
• Peri-ampullary Cancer

Intervention

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.
• Placebo
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei university of medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complication that related with infection.		within 10 days
Secondary	Rate of post-ERCP cholangitis		within 10 days
Secondary	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