|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Florida |
|---|---|
| Information provided by: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00861198 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Disorders of the Pancreas and Biliary Tree |
Other: ERCP as per medical indication |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Mangement of Pancreaticobiliary Disorders |
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: ERCP as per medical indication
ERCP as per medical indication
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter Draganov, MD | 352-392-2877 | peter.draganov@medicine.ufl.edu |
| United States, Florida | |
| Shands UF endoscopy Center | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Peter Draganov, MD 352-392-2877 peter.draganov@medicine.ufl.edu | |
| Principal Investigator: Peter Draganov, MD | |
| Sub-Investigator: Chris Forsmark, MD | |
| Sub-Investigator: Mamoon Elbedawi, MD | |
| Principal Investigator: | Peter Draganov, MD | University of Florida, Division of Gastroenterology |
More Information
| Responsible Party: | University of Florida, Division of Gastroenterology ( Peter Draganov MD ) |
| Study ID Numbers: | Pancreaticobiliary disorders |
| Study First Received: | March 12, 2009 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00861198 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Pathologic Processes Disease |
