The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders

Study Overview
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Brief Summary
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At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the pancreaticobiliary system is done indirectly by radiologic means. Contrast is injected into the bile and/or pancreatic duct and outline of the duct is then viewed by fluoroscopic imaging. Frequently this is followed by diagnostic maneuvers (tissue acquisition) or therapeutic interventions (stone removal, stent insertion). Direct visualization of the bile and pancreatic ducts (cholangioscopy/pancreatoscopy) was developed 15 years ago and was shown to be superior to the indirect radiological view. The procedure did not become widely used secondary to high procedure related costs and equipment prone to failure. Recently a much improved (more affordable and more durable) cholangioscope was developed and approved by the FDA. The goal of this study is to prospectively record our experience with cholangioscopy and pancreatoscopy performed as medically indicated as part of standard medical care.

Official Title
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The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders

Conditions
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Disorders of the Pancreas and Biliary Tree

Intervention / Treatment
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* Other: ERCP as per medical indication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years or older. Scheduled to undergo ERCP with cholangioscopy and/or pancreatoscopy at the University of Florida, Gainesville, FL as medically indicated. Subject must be able to give informed consent Exclusion Criteria: Any contraindication to ERCP. The subject is unable to give informed consent.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERCP<br>Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study. | Other: ERCP as per medical indication<br>* ERCP as per medical indication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Procedure Completion | Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings. | baseline |