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

This study is currently recruiting participants.

Verified April 2013 by Texas Tech University Health Sciences Center

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: April 17, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2012

Last Updated Date

April 17, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01673269 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Choledocholithiasis
Cholangiocarcinoma
Benign Stricture of Common Bile Duct

Intervention ^ICMJE

Other: Blood culture ( aerobic and anaerobic)

Blood culture 5 minutes and 30 minutes after the procedure

Study Arm (s)

Experimental: ERCP with direct examination of the CBD

Intervention: Other: Blood culture ( aerobic and anaerobic)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mohamed o Othman, MD	915-545-6640	mohamed.othman@ttuhsc.edu
Contact: Mark Zuckerman, MD	915-545-6640	mark.zuckerman@ttuhsc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01673269

Other Study ID Numbers ^ICMJE

E12053-A

Has Data Monitoring Committee

Yes

Responsible Party

Texas Tech University Health Sciences Center

Study Sponsor ^ICMJE

Texas Tech University Health Sciences Center

Collaborators ^ICMJE

American College of Gastroenterology

Investigators ^ICMJE

Principal Investigator:

Mohamed O Othman, MD

Texas Tech University at El Paso

Information Provided By

Texas Tech University Health Sciences Center

Verification Date

April 2013

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

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