Clinical trial NCT02524418: Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
Official title: Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Disease
Keywords: Main Pancreatic Duct
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Procedure Technical Success
timeFrame: Day 1
Secondary outcomes:
measure: Time to Set-up the Spyglass DS for the Procedure
timeFrame: approximately 2 hours
measure: Measurement of Total Procedure Time Using the Spyglass DS
timeFrame: approximately 2 hours
measure: Measurement in Minutes for Spyglass DS Diagnostic Maneuvers
timeFrame: approximately 2 hours
measure: Measurement in Minutes for Spyglass DS Therapeutic Maneuvers
timeFrame: approximately 2 hours
measure: Number of Cholangioscopic Exams That Detected Ductal Stones
timeFrame: Day 1
measure: Strictures Found During the Procedure Will be Measured
timeFrame: Day 1
measure: Spybite Sampling Attempts Per Procedure
timeFrame: Day 1
measure: Number of Participants With Successful Removal of the Biliary or Pancreas Stones
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Peter V Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References: