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

Brief Title

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


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.
    



Study Type

Interventional


Primary Outcome

Rate of complication that related with infection.

Secondary Outcome

 Rate of post-ERCP cholangitis

Condition

Biliary Obstructive Disease Such as Choledocholithiasis

Intervention

Pacetin® (cefoxitin)

Study Arms / Comparison Groups

 Treatment
Description:  The intervention group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

400

Start Date

December 1, 2016

Completion Date

August 2020

Primary Completion Date

August 2020

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
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +82-02-2228-1995, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02958059

Organization ID

4-2015-0596


Responsible Party

Sponsor

Study Sponsor

Yonsei University


Study Sponsor

, , 


Verification Date

January 2019