Status:
COMPLETED
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).
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Bile Duct Stricture
Choledocholithiasis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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/sepsi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 18-80
- Biliary disease such as large stones necessitating electrohydraulic lithotripsy;
- Biliary strictures needing tissue acquisition through cholangioscopic directed biopsies
- Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion
- Age \<18, \> 80
- Potentially vulnerable subjects including pregnant women, homeless people, employees and students.
- Patients who have a clear indication for pre-procedure antibiotics based on current ASGE guidelines
- Patients who had received antibiotics for any reason within the prior 7 days
- Patients who had evidence of systemic infection at time of the ERCP
- Patients in whom additional venous access for blood cultures cannot be established.
- Participation in another investigational study within the previous 90 days
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01414400
Start Date
August 1 2011
End Date
December 1 2015
Last Update
March 14 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305