Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Biliary Tract Disease

Intervention / Treatment
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* Procedure: Cholangiopancreatoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cholangiopancreatoscopy<br>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<br>* An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.<br>* Other names: ERCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | approximately 2 hours | 
| Measurement of Total Procedure Time Using the Spyglass DS | 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 | 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 | 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 | The abnormalities found during the procedure, such as ductal stones. | Day 1 | 
| Strictures Found During the Procedure Will be Measured | The abnormalities found during the procedure, such as strictures. | Day 1 | 
| Spybite Sampling Attempts Per Procedure | The mean number of attempts per procedure | Day 1 | 
| 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Main Pancreatic Duct