Clinical Trial: Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Florida

Current Primary Outcome: Number of Participants With Procedure Technical Success [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Time to set-up the Sypglass DS for the procedure [ Time Frame: approximately 2 hours ]
    The time it takes to set up the Spyglass DS and related equipment for the procedure.
  • Measurement of Total Procedure Time Using the Spyglass DS [ Time Frame: 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 [ Time Frame: approximately 2 hours ]
    The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.
  • Measurement in Minutes for Spyglass DS Therapeutic Maneuvers [ Time Frame: approximately 2 hours ]
    The time it takes to perform the therapeutic maneuvers with the SpyGlass DS measured in minutes.
  • Ductal stones found during the procedure will be measured [ Time Frame: Day 1 ]
    The abnormalities found during the procedure, such as ductal stones.
  • Strictures Found During the Procedure Will be Measured [ Time Frame: Day 1 ]
    The abnormalities found during the procedure, such as strictures.
  • Biopsy sample size will be measured in millimeters [ Time Frame: Day 1 ]
    The size of the biopsy sample will be measures in millimeters.
  • The ability for Sypglass DS in removing stones [ Time Frame: Day 1 ]
    The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.
  • Number of subjects with Adverse Events [ Time Frame: 24 hours ]
    Number of subjects with Adverse Events


Information By: University of Florida

Dates:
Date Received: August 7, 2015
Date Started: August 2015
Date Completion:
Last Updated: February 10, 2017
Last Verified: February 2017