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NCT00861198 · ClinicalTrials.gov registry record
The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
A clinical trial of Disorders of the Pancreas and Biliary Tree, sponsored by University of Florida.
- Completed
- Registry status
- 88
- Enrollment target
- 1
- Study location
NCT00861198: Completed study of Disorders of the Pancreas and Biliary Tree, sponsored by University of Florida.
NCT00861198 is a study of Disorders of the Pancreas and Biliary Tree that has completed, run by University of Florida. The registered enrollment target is 88 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00861198, a study of Disorders of the Pancreas and Biliary Tree, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 88 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 diagno
Conditions Studied
Interventions
- OTHER ERCP as per medical indication
Study Locations (1)
Florida
- Shands UF endoscopy Center - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2006-11 |
| Est. Completion | 2015-05 |
What the finished NCT00861198 record still lists
NCT00861198 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 88 participants, a relatively small participant target.
The record links to 1 condition, with Disorders of the Pancreas and Biliary Tree appearing as the primary indexed condition, and to 1 intervention - of which ERCP as per medical indication is the first listed.
NCT00861198 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00861198 about?
NCT00861198 is a clinical study titled "The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders". 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 follo...
What is the current status of trial NCT00861198?
This trial is currently completed. The enrollment target is 88 participants. The study started on 2006-11. Estimated completion is 2015-05.
What conditions does trial NCT00861198 study?
This clinical trial studies the following conditions: Disorders of the Pancreas and Biliary Tree.
What interventions are being tested in trial NCT00861198?
The interventions under investigation include: ERCP as per medical indication (OTHER).
Who is sponsoring clinical trial NCT00861198?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00861198 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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