Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS (SPYDS)

February 10, 2017 updated by: University of Florida

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 pancreatic-biliary disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at the University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cholangiopancreatoscopy
A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Procedure: Cholangiopancreatoscopy
An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Other Names:
  • ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 2 hours
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.
approximately 2 hours
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.
approximately 2 hours
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.
approximately 2 hours
Number of Cholangioscopic Exams That Detected Ductal Stones
Time Frame: Day 1
The abnormalities found during the procedure, such as ductal stones.
Day 1
Strictures Found During the Procedure Will be Measured
Time Frame: Day 1
The abnormalities found during the procedure, such as strictures.
Day 1
Spybite Sampling Attempts Per Procedure
Time Frame: Day 1
The mean number of attempts per procedure
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 483-2006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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