Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Choledocholithiasis
- Sponsor
- Texas Tech University Health Sciences Center, El Paso
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Mohamed O Othman
Assistant Professor
Texas Tech University Health Sciences Center, El Paso
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.
Outcomes
Primary Outcomes
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 Outcomes
- To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD(within 24 hours and one week of the procedures.)