Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
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|ClinicalTrials.gov Identifier: NCT02543957|
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : January 16, 2019
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 :
- The removal of all stones from the participants bile duct (if present).
- Acquiring a tissue sample biopsy from any common bile mass to examine (if present).
- 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.
|Condition or disease||Intervention/treatment|
|Cholangitis Bacteremia||Procedure: Cholangioscopy|
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||A Prospective Study of the Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
- Procedure: Cholangioscopy
All patients will receive pre-procedural antibiotics per protocol. A blood culture will be drawn from patients prior to the procedure (before antibiotics administration), 5 minutes after the procedure and 30 minutes after the procedure. Patients will be followed up for 7 days after the procedure for fever and or sepsis.
- Examine the Incidence of new onset infectious complications [ Time Frame: 7 days ]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.
- Examine the incidence of bacteremia in patients undergoing ERCP with cholangioscopy [ Time Frame: 7 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543957
|Contact: Mohamed O. Othman, MD||713-798-0950||Mohamed.Othman@bcm.edu|
|Contact: Nedaa Husainat||713-798-0947||Nedaa.Husainat@bcm.edu|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mohamed O. Othman, MD 713-798-0950 Mohamed.Othman@bcm.edu|
|Principal Investigator:||Mohamed Othman, MD||Baylor College of Medicine|