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

University of Florida

Status: Completed

Conditions: Biliary Tract Disease

Treatments: Procedure: Cholangiopancreatoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02524418

483-2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Cholangiopancreatoscopy

Other group

Description:

A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.

Treatment:

Procedure: Cholangiopancreatoscopy