Bacteremia Clinical Trial
Official title:
A Prospective Study of the Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
NCT number | NCT02543957 |
Other study ID # | H-37346 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | December 2020 |
Verified date | January 2021 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
An Endoscopic retrograde cholangio pancreatography (ERCP) with cholangioscopy (endoscope to directly visualize the bile duct ) is a procedure (a small flexible tube that is inserted into the participants mouth to the participants stomach and into the participants liver to visualize the bile duct) that is usually performed in patients for the following purposes : 1. The removal of all stones from the participants bile duct (if present). 2. Acquiring a tissue sample biopsy from any common bile mass to examine (if present). 3. Acquiring tissue sample biopsy from common bile duct narrowing (if present). However this procedure is associated with an increase risk of infection compared with the standard ERCP (ERCP without cholangioscopy). Previous studies have shown that despite the administration of antibiotics prior to these procedures, infection still occurs. This leads to a suspicion that other factors may be the cause in these infections. Factors such as age, race, gender and ethnicity have not been fully explored yet. This study aims to examine these factors in addition to others in patients who are undergoing ERCP with cholangioscopy as part of their routine medical care. This examination will allow us to bring out if any of the above mentioned factors may be involved in the development of an infection after ERCP with cholangioscopy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Adult patients (18-80) who are undergoing ERCP with cholangioscopy to ensure the clearance of the CBD from stones. 2. Adult patients (18-80) who are undergoing ERCP with cholangioscopy for CBD stone removal using laser lithotripsy. 3. Adult patients (18-80) who are undergoing ERCP with cholangioscopy for CBD mass. 4. Adult patients (18-80) who are undergoing ERCP with cholangioscopy for tissue acquisition from CBD strictures with biopsies. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Examine the Incidence of new onset infectious complications | 1- To examine the incidence and risk factors of new onset infectious complications such as fever, sepsis or cholangitis within one week after ERCP with cholangioscopy. | 7 days | |
Secondary | Examine the incidence of bacteremia in patients undergoing ERCP with cholangioscopy | Existing prospective data have shown bacteremia in 8.8% of patients undergoing ERCP with cholangioscopy, thus promoting the use of prophylactic antibiotics in patients undergoing these procedures. Three blood withdrawals from the patient undergoing ERCP with Cholangioscopy. One blood withdrawal will be taken before the procedure (Cholangioscopy), the second one will be taken 5 minutes after the procedure and the last blood withdrawal will be taken 30 minutes after the procedure with an overall 30 cc blood withdrawn from each patient. Aseptic techniques will be taken to minimize the contamination of the blood sample by the skin flora. Patients with positive blood culture for bacteremia will be monitored and only patients with fever and evidence of sepsis or cholangitis will be treated with antibiotics. The patient will receive a phone questionnaire about adverse affects that might have happened after the procedure 24 hours after the procedure and 1 week after the procedure. | 7 days |
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