Brief Title
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Official Title
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
Interventional
Primary Outcome
the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD
Secondary Outcome
To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD
Condition
Choledocholithiasis
Intervention
Blood culture ( aerobic and anaerobic)
Study Arms / Comparison Groups
ERCP with direct examination of the CBD
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
60
Start Date
July 2012
Completion Date
October 2013
Primary Completion Date
October 2013
Eligibility 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.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Mohamed O Othman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01673269
Organization ID
E12053-A
Responsible Party
Principal Investigator
Study Sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborators
American College of Gastroenterology
Study Sponsor
Mohamed O Othman, MD, Principal Investigator, Texas Tech University at El Paso
Verification Date
May 2017