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).
NCT01414400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-03-14
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/sepsis despite use of post procedural antibiotics will be studied.
Conditions
- Bile Duct Stricture
- Choledocholithiasis
Interventions
- OTHER
-
Blood draw for culture
Blood will be drawn and sent for culture.
Sponsors & Collaborators
-
Boston Scientific Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Subhas Banerjee, MD · Stanford University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2015-08-31
- Completion
- 2015-12-31
Countries
- United States
Study Locations
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