Prospective Study to Investigate the Frequency of Possible Bacterial Entry Into the Bloodstream (Bacteremia) and Infectious Complications Associated With the Use of the Spyglass Cholangioscopy System During ERCP (Endoscopic Retrograde Cholangiopancreatography).

Trial ID: NCT01414400

Purpose

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.

Official Title

Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope

Stanford Investigator(s)

Subhas Banerjee
Subhas Banerjee

Professor of Medicine (Gastroenterology and Hepatology)

Eligibility


Inclusion Criteria:

   1. Age 18-80

   2. Biliary disease such as large stones necessitating electrohydraulic lithotripsy;

   3. Biliary strictures needing tissue acquisition through cholangioscopic directed
   biopsies

   4. Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic
   directed biopsies

   5. Willing and able to comply with the study procedures and provide written informed
   consent to participate in the study.

Exclusion Criteria:

   1. Age <18, > 80

   2. Potentially vulnerable subjects including pregnant women, homeless people, employees
   and students.

   3. Patients who have a clear indication for pre-procedure antibiotics based on current
   ASGE guidelines

   4. Patients who had received antibiotics for any reason within the prior 7 days

   5. Patients who had evidence of systemic infection at time of the ERCP

   6. Patients in whom additional venous access for blood cultures cannot be established.

   7. Participation in another investigational study within the previous 90 days

Intervention(s):

other: Blood draw for culture

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Subhas Banerjee, MD