Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2015
End Date:June 2020
Contact:Peter V Draganov, MD
Email:dragapv@medicine.ufl.edu
Phone:352-273-9474

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Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.

This is a prospective evaluation of the clinical utility of the new cholangioscopy platform
SpyGlass DS. The aims of this study are to prospectively document the clinical utility and
technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and
management of pancreata-biliary disorders.

Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the
SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and
since then has been shown to provide incremental diagnostic and therapeutic benefits. The
main limitations of the original SpyGlass platform are fiberoptic visualization system,
limited tip angulation, square cut Spy scope tip, and complex multicomponent setup. A new
generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system
addresses many of the shortcomings of old platform including digital optics, improved tip
angulation, tapered tip and simplified set up. It is unclear at this time wether this
technical improvement will translate into better outcomes. Therefore, the investigators want
to study the clinical utility of SpyGlass DS by prospectively collecting data on the
clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their
routine medical care.

Inclusion Criteria:

- Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine
clinical care

Exclusion Criteria:

- failure to provide informed consent

- any contraindications to endoscopy
We found this trial at
1
site
Gainesville, Florida 32610
Principal Investigator: Peter V Draganov, MD
Phone: 352-273-9400
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Gainesville, FL
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