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Trial record 3 of 3 for:    "Cholangitis" | "Antitubercular Agents"

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

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ClinicalTrials.gov Identifier: NCT02958059
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Biliary Obstructive Disease Such as Choledocholithiasis Benign Biliary Stricture Peri-ampullary Cancer Bile Duct Cancer Resectable Klatskin Tumor Biological: Pacetin® (cefoxitin) Biological: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Cefoxitin

Arm Intervention/treatment
Experimental: Treatment
The intervention group
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.
Other Name: Antibiotic prophylaxis

Placebo Comparator: Comparator
The comparator group
Biological: Placebo
10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
Other Name: normal saline




Primary Outcome Measures :
  1. Rate of complication that related with infection. [ Time Frame: within 10 days ]

Secondary Outcome Measures :
  1. Rate of post-ERCP cholangitis [ Time Frame: within 10 days ]
  2. Grade of post-ERCP infectious complication [ Time Frame: 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958059


Contacts
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Contact: Seung Min Bang, MD +82-02-2228-1995 BANG7028@yuhs.ac

Locations
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Korea, Republic of
Yonsei university of medical center Recruiting
Seoul, Korea, Republic of, 03722
Contact: Seung Min Bang, MD    +82 2 2228 1995    BANG7028@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02958059     History of Changes
Other Study ID Numbers: 4-2015-0596
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
ERCP
prophylaxis
antibiotics
infection
cholangitis
Additional relevant MeSH terms:
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Antibiotics, Antitubercular
Antitubercular Agents
Bile Duct Neoplasms
Cholangiocarcinoma
Klatskin Tumor
Choledocholithiasis
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Common Bile Duct Diseases
Cholelithiasis
Anti-Bacterial Agents
Cefoxitin
Cefotaxime
Anti-Infective Agents