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 or NCT#

NCT01414400

Status

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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

Investigator(s)

Subhas Banerjee
Subhas Banerjee
Gastroenterologist, Therapeutic endoscopy specialist, Biliary specialist, Endoscopic ultrasound specialist
Professor of Medicine (Gastroenterology and Hepatology)

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Contact

Subhas Banerjee, MD