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Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD

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ClinicalTrials.gov Identifier: NCT01673269
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The tube passes beyond the stomach and into an opening in the liver called the bile duct. Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to take a sample from the bile duct. The purpose of our study is to examine wither performing this procedure can transmit bacteria from the bile duct to the main blood stream.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Cholangiocarcinoma Benign Stricture of Common Bile Duct Other: Blood culture ( aerobic and anaerobic) Not Applicable

Detailed Description:
This is a prospective study to measure the frequency of bacteremia in patients undergoing ERCP with direct cholangioscopic examination of the Common Bile Duct "CBD". A blood culture will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30 minutes after the procedure. The patient will be followed up for 7 days after procedure for fever and sepsis. The estimated sample size is 60 patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Study Start Date : July 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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MedlinePlus related topics: Health Checkup
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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ERCP with direct examination of the CBD Other: Blood culture ( aerobic and anaerobic)
Blood culture 5 minutes and 30 minutes after the procedure


Outcome Measures
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Primary Outcome Measures :
  1. the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD [ Time Frame: 5 minutes and 30 minutes ]
    To measure the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD by obtaining blood culture 5 minutes and 30 minutes after the procedure


Secondary Outcome Measures :
  1. To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD [ Time Frame: within 24 hours and one week of the procedures. ]
    This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct to ensure the clearance of the common bile duct from stones.

    2- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for stone removal.

    3- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from the common bile duct mass.

    4- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from common bile duct strictures.

Exclusion Criteria:

  • 1- Patients younger than 18 yrs old or older than 80 yrs. 2- Pregnant patients. 3- Patient with ascending cholangitis, pneumonia or urinary tract infection 4- Patients who received antibiotics in the last 2 weeks prior to the procedure.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01673269


Locations
United States, Texas
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
American College of Gastroenterology
Investigators
Principal Investigator: Mohamed O Othman, MD Texas Tech University at El Paso
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mohamed O Othman, Assistant Professor, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT01673269     History of Changes
Other Study ID Numbers: E12053-A
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso:
ERCP
Direct cholangioscopic examination of the common bile duct
Choledocholithiasis
Cholangiocarcinoma
Benign stricture of common bile duct

Additional relevant MeSH terms:
Cholangiocarcinoma
Bacteremia
Constriction, Pathologic
Choledocholithiasis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bacterial Infections
Sepsis
 Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis