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This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.
Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. The main limitations of the original SpyGlass platform are fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component setup. A new generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. It is unclear at this time whether this technical improvement will translate into better outcomes. Therefore, the investigators want to study the clinical utility of SpyGlass DS by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their routine medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholangiopancreatoscopy | Other | A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholangiopancreatoscopy | Procedure | An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Procedure Technical Success | The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Set-up the Spyglass DS for the Procedure | The time it takes to set up the Spyglass DS and related equipment for the procedure. | approximately 2 hours |
| Measurement of Total Procedure Time Using the Spyglass DS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter V Draganov, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands at the University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholangiopancreatoscopy | A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
88 subjects signed consent but in 13 subjects a Spyglass examination was not done because of the lack of indication after performing standard cholangiography or pancreatography
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholangiopancreatoscopy | A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed. |
| 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 | Number of Participants With Procedure Technical Success | The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention. | Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately | Posted | Number | participants | Day 1 |
|
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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 | Cholangiopancreatoscopy | A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| periampullary perforation | Gastrointestinal disorders | Systematic Assessment | Serious AE with periampullary perforation caused by biliary sphincterotomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild Post ERCP pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter V. Draganov MD | University of Florida | 352-273-9472 | peter.draganov@medicine.ufl.edu |
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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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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|
Time in minutes will be calculated for completing the procedure with the Spyglass DS.
| approximately 2 hours |
| Measurement in Minutes for Spyglass DS Diagnostic Maneuvers | The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes. | approximately 2 hours |
| Measurement in Minutes for Spyglass DS Therapeutic Maneuvers | The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes. | approximately 2 hours |
| Number of Cholangioscopic Exams That Detected Ductal Stones | The abnormalities found during the procedure, such as ductal stones. | Day 1 |
| Strictures Found During the Procedure Will be Measured | The abnormalities found during the procedure, such as strictures. | Day 1 |
| Spybite Sampling Attempts Per Procedure | The mean number of attempts per procedure | Day 1 |
| Number of Participants With Successful Removal of the Biliary or Pancreas Stones | The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures. | Day 1 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pancreatoscopy |
These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP |
|
|
| Secondary | Time to Set-up the Spyglass DS for the Procedure | The time it takes to set up the Spyglass DS and related equipment for the procedure. | In 20 procedures, the Spyglass equipment set up was done after ERCP started and this time was recorded. The Investigators did not record the set up time for the other procedures. | Posted | Mean | Full Range | minutes | approximately 2 hours |
|
|
|
| Secondary | Measurement of Total Procedure Time Using the Spyglass DS | Time in minutes will be calculated for completing the procedure with the Spyglass DS. | 83 Spyglass procedures were conducted on the 75 participants | Posted | Mean | Full Range | minutes | approximately 2 hours | number of Spyglass procedures | number of Spyglass procedures |
|
|
|
| Secondary | Measurement in Minutes for Spyglass DS Diagnostic Maneuvers | The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes. | 83 Spyglass procedures were performed on the 75 participants | Posted | Mean | Full Range | minutes | approximately 2 hours | number of Spyglass Proceudres | number of Spyglass Proceudres |
|
|
|
| Secondary | Measurement in Minutes for Spyglass DS Therapeutic Maneuvers | The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes. | For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants. | Posted | Mean | Full Range | minutes | approximately 2 hours | Number of Procedures analyzed | Number of Procedures analyzed |
|
|
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| Secondary | Number of Cholangioscopic Exams That Detected Ductal Stones | The abnormalities found during the procedure, such as ductal stones. | There were a total of 78 Cholangioscopic examinations in the 70 subjects in this study; 35 exam found stones. Where as in the Pancreatoscopy arm 5 participants were evaluated with only 3 exams being evaluable.. | Posted | Number | exams | Day 1 | total number of exams | total number of exams |
|
|
|
| Secondary | Strictures Found During the Procedure Will be Measured | The abnormalities found during the procedure, such as strictures. | A total of 78 Cholangioscopic examinations were attempted | Posted | Number | strictures found | Day 1 | attempted Cholangioscopic exams | attempted Cholangioscopic exams |
|
|
|
| Secondary | Spybite Sampling Attempts Per Procedure | The mean number of attempts per procedure | Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures. | Posted | Mean | Full Range | sampling attempts per procedure | Day 1 | Number of procedures analyzed | Number of procedures analyzed |
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| Secondary | Number of Participants With Successful Removal of the Biliary or Pancreas Stones | The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures. | Spyglass-guided stone therapy was attempted in 26 patients with biliary stones | Posted | Number | participants | Day 1 |
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|
| 1 |
| 75 |
| 3 |
| 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 |