Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

Biliary Tract Disease Clinical Trial

— SPYDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02524418
• Other study ID #: 483-2006
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2015
• Last updated: March 9, 2016
• Start date: August 2015
• Est. completion date: June 2020

Study information

• Verified date: March 2016
• Source: University of Florida
• Contact: Peter V Draganov, MD
• Phone: 352-273-9474
• Email: dragapv[@]medicine.ufl.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 pancreata-biliary disorders.

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 fiberoptic visualization system, limited tip angulation, square cut Spy scope tip, and complex multicomponent 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 wether 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biliary Tract Disease
• Biliary Tract Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Shands at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to set-up the Sypglass DS for the procedure	The time it takes to set up the Spyglass DS and related equipment for the procedure.	approximately 2 hours	No
Secondary	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	No
Secondary	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	No
Secondary	Measurement in minutes for Spyglass DS therapeutic maneuvers	The time it takes to perform the therapeutic maneuvers with the SpyGlass DS measured in minutes.	approximately 2 hours	No
Secondary	Ductal stones found during the procedure will be measured	The abnormalities found during the procedure, such as ductal stones.	Day 1	No
Secondary	Strictures found during the procedure will be measured	The abnormalities found during the procedure, such as strictures.	Day 1	No
Secondary	Biopsy sample size will be measured in millimeters	The size of the biopsy sample will be measures in millimeters.	Day 1	No
Secondary	The ability for Sypglass DS in removing stones	The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.	Day 1	No
Secondary	Number of subjects with Adverse Events	Number of subjects with Adverse Events	24 hours	Yes