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

This study has been completed.
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01673269
First received: August 22, 2012
Last updated: November 25, 2013
Last verified: November 2013

August 22, 2012
November 25, 2013
July 2012
October 2013   (final data collection date for primary outcome measure)
the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD [ Time Frame: 5 minutes and 30 minutes ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01673269 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: Yes ]
This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure
Same as current
Not Provided
Not Provided
 
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Choledocholithiasis
  • Cholangiocarcinoma
  • Benign Stricture of Common Bile Duct
Other: Blood culture ( aerobic and anaerobic)
Blood culture 5 minutes and 30 minutes after the procedure
Experimental: ERCP with direct examination of the CBD
Intervention: Other: Blood culture ( aerobic and anaerobic)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01673269
E12053-A
Yes
Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
American College of Gastroenterology
Principal Investigator: Mohamed O Othman, MD Texas Tech University at El Paso
Texas Tech University Health Sciences Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP