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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP as per medical indication | Other | ERCP as per medical indication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Draganov, MD | University of Florida, Division of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands UF endoscopy Center | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21419408 | Derived | Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17. |
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There were 88 participants who were enrolled into the study; however, 13 were excluded because they did not qualify for the SpyGlass examination.
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| ID | Title | Description |
|---|---|---|
| FG000 | ERCP With Cholangioscopy and/or Pancretoscopy | Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ERCP With Cholangioscopy and/or Pancretoscopy | Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | baseline |
|
The reporting data was collected for 1 week after the procedure date
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: ERCP as per medical indication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter V. Draganov | University of Florida | (352) 273-9472 | Peter.Draganov@medicine.ufl.edu |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 75 |
| 0 |
| 75 |
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |