Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

Not Applicable

Completed

Brief Summary: 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 pancreatic-biliary disorders.

Detailed Description: 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 fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component 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 whether 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Cholangiopancreatoscopy	Cholangiopancreatoscopy	A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedure Technical Success	Day 1	The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.

Secondary Outcome Measures

Name	Time	Method
Measurement of Total Procedure Time Using the Spyglass DS	approximately 2 hours	Time in minutes will be calculated for completing the procedure with the Spyglass DS.
Measurement in Minutes for Spyglass DS Diagnostic Maneuvers	approximately 2 hours	The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.
Number of Participants With Successful Removal of the Biliary or Pancreas Stones	Day 1	The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.
Measurement in Minutes for Spyglass DS Therapeutic Maneuvers	approximately 2 hours	The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.
Time to Set-up the Spyglass DS for the Procedure	approximately 2 hours	The time it takes to set up the Spyglass DS and related equipment for the procedure.
Number of Cholangioscopic Exams That Detected Ductal Stones	Day 1	The abnormalities found during the procedure, such as ductal stones.
Strictures Found During the Procedure Will be Measured	Day 1	The abnormalities found during the procedure, such as strictures.
Spybite Sampling Attempts Per Procedure	Day 1	The mean number of attempts per procedure

Locations (1): Shands at the University of Florida
🇺🇸
Gainesville, Florida, United States