Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS (SPYDS)
Primary Purpose
Biliary Tract Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholangiopancreatoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Biliary Tract Disease focused on measuring Main Pancreatic Duct
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
Sites / Locations
- Shands at the University of Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cholangiopancreatoscopy
Arm Description
A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Outcomes
Primary Outcome Measures
Number of Participants With Procedure Technical Success
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
Time to Set-up the Spyglass DS for the Procedure
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 in minutes will be calculated for completing the procedure with the Spyglass DS.
Measurement in Minutes for Spyglass DS Diagnostic Maneuvers
The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.
Measurement in Minutes for Spyglass DS Therapeutic Maneuvers
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
The abnormalities found during the procedure, such as ductal stones.
Strictures Found During the Procedure Will be Measured
The abnormalities found during the procedure, such as strictures.
Spybite Sampling Attempts Per Procedure
The mean number of attempts per procedure
Number of Participants With Successful Removal of the Biliary or Pancreas Stones
The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.
Full Information
NCT ID
NCT02524418
First Posted
August 7, 2015
Last Updated
February 10, 2017
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT02524418
Brief Title
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
Acronym
SPYDS
Official Title
Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Disease
Keywords
Main Pancreatic Duct
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cholangiopancreatoscopy
Arm Type
Other
Arm Description
A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Intervention Type
Procedure
Intervention Name(s)
Cholangiopancreatoscopy
Other Intervention Name(s)
ERCP
Intervention Description
An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Primary Outcome Measure Information:
Title
Number of Participants With Procedure Technical Success
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Time to Set-up the Spyglass DS for the Procedure
Description
The time it takes to set up the Spyglass DS and related equipment for the procedure.
Time Frame
approximately 2 hours
Title
Measurement of Total Procedure Time Using the Spyglass DS
Description
Time in minutes will be calculated for completing the procedure with the Spyglass DS.
Time Frame
approximately 2 hours
Title
Measurement in Minutes for Spyglass DS Diagnostic Maneuvers
Description
The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.
Time Frame
approximately 2 hours
Title
Measurement in Minutes for Spyglass DS Therapeutic Maneuvers
Description
The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.
Time Frame
approximately 2 hours
Title
Number of Cholangioscopic Exams That Detected Ductal Stones
Description
The abnormalities found during the procedure, such as ductal stones.
Time Frame
Day 1
Title
Strictures Found During the Procedure Will be Measured
Description
The abnormalities found during the procedure, such as strictures.
Time Frame
Day 1
Title
Spybite Sampling Attempts Per Procedure
Description
The mean number of attempts per procedure
Time Frame
Day 1
Title
Number of Participants With Successful Removal of the Biliary or Pancreas Stones
Description
The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter V Draganov, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
We'll reach out to this number within 24 hrs