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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2015-05-31

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.

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Detailed Description

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Conditions

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Disorders of the Pancreas and Biliary Tree

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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ERCP

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.

ERCP as per medical indication

Intervention Type OTHER

ERCP as per medical indication

Interventions

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ERCP as per medical indication

Intervention Type OTHER

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