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

Not Applicable

• Conditions: Bile Duct Cancer Resectable; Klatskin Tumor; Biliary Obstructive Disease Such as Choledocholithiasis; Peri-ampullary Cancer; Benign Biliary Stricture
• Interventions: Biological: Placebo; Biological: Pacetin® (cefoxitin)

• Registration Number: NCT02958059
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Study Start: 2016-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with biliary obstructive disease (Benign or Malignant)
• 19 year-old and older than 19 year-old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator	Placebo	The comparator group
Treatment	Pacetin® (cefoxitin)	The intervention group

Primary Outcome Measures

Name	Time	Method
Rate of complication that related with infection.	within 10 days

Secondary Outcome Measures

Name	Time	Method
Rate of post-ERCP cholangitis	within 10 days
Grade of post-ERCP infectious complication	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

Trial Locations

Locations (1)

Yonsei university of medical center; 🇰🇷 Seoul, Korea, Republic of