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

University of Florida88 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Disorders of the Pancreas and Biliary Tree

Interventions

ERCP as per medical indicationOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: baseline