N/A
N=75
The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
Disorders of the Pancreas and Biliary Tree
Bottom Line
View on ClinicalTrials.gov: NCT00861198 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Successful Procedure Completion — 70; 5 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ERCP as per medical indication (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Procedure Completion |
70; 5 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00861198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.