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).

Rates of bacteremia (bacterial seeding of the blood) following ERCP's range from 6.4% to
18.0%. However, infectious complications of cholangitis/sepsis occur in only 0.5%- 3.0% of
patients undergoing this procedure. The Spyglass Direct Visualization System allows
cholangioscopy with direct visualization of the bile duct during ERCP by using a specialized
small caliber endoscope. During the Spyglass portion of the procedure, saline is introduced
into the bile duct to to irrigate the biliary system, in order to distend the biliary ducts
and to improve visualization by clearing contrast, pus and stone debris. Saline irrigation
may increase intrabiliary pressures and may therefore theoretically increase the risk for
bacteremia and infection.

The effect of Spyglass cholangioscopy and biliary irrigation on the frequency of
bacteremia/post cholangioscopy infections is unknown and has not previously been studied.

The aim of this study is to prospectively evaluate the frequency of bacteremia after
ERCP/cholangioscopy using the Spyglass system.

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