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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

The intervention group

Group Type EXPERIMENTAL

Pacetin® (cefoxitin)

Intervention Type BIOLOGICAL

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.

Comparator

The comparator group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Antibiotic prophylaxis normal saline

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No