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Completed

NCT Number: NCT02524418

Clinical Utility of 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.

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Key information

Conditions

Biliary Tract Disease Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholangiopancreatoscopy

Procedure

An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.

Other names: ERCP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of Cholangioscopic Exams That Detected Ductal Stones

    Time frame: Day 1

    The abnormalities found during the procedure, such as ductal stones.

  6. Strictures Found During the Procedure Will be Measured

    Time frame: Day 1

    The abnormalities found during the procedure, such as strictures.

  7. Spybite Sampling Attempts Per Procedure

    Time frame: Day 1

    The mean number of attempts per procedure

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: SPYDS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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