Biliary Tract Disease
Conditions
Keywords
Main Pancreatic Duct
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECholangiopancreatoscopy
An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care
Exclusion criteria
* failure to provide informed consent * any contraindications to endoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedure Technical Success | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Total Procedure Time Using the Spyglass DS | approximately 2 hours | Time in minutes will be calculated for completing the procedure with the Spyglass DS. |
| Measurement in Minutes for Spyglass DS Diagnostic Maneuvers | approximately 2 hours | The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes. |
| Measurement in Minutes for Spyglass DS Therapeutic Maneuvers | approximately 2 hours | The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes. |
| Time to Set-up the Spyglass DS for the Procedure | approximately 2 hours | The time it takes to set up the Spyglass DS and related equipment for the procedure. |
| Strictures Found During the Procedure Will be Measured | Day 1 | The abnormalities found during the procedure, such as strictures. |
| Spybite Sampling Attempts Per Procedure | Day 1 | The mean number of attempts per procedure |
| Number of Participants With Successful Removal of the Biliary or Pancreas Stones | Day 1 | The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures. |
| Number of Cholangioscopic Exams That Detected Ductal Stones | Day 1 | The abnormalities found during the procedure, such as ductal stones. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Cholangiopancreatoscopy |
|---|---|
| Age, Continuous | 66 years |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 75 |
| serious Total, serious adverse events | 1 / 75 |
Outcome results
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.
Time frame: Day 1
Population: Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cholangioscopy | Number of Participants With Procedure Technical Success | 70 participants |
| Pancreatoscopy | Number of Participants With Procedure Technical Success | 3 participants |
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.
Time frame: approximately 2 hours
Population: 83 Spyglass procedures were performed on the 75 participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cholangioscopy | Measurement in Minutes for Spyglass DS Diagnostic Maneuvers | 27.5 minutes |
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.
Time frame: approximately 2 hours
Population: For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cholangioscopy | Measurement in Minutes for Spyglass DS Therapeutic Maneuvers | 12.1 minutes |
Secondary
Measurement of Total Procedure Time Using the Spyglass DS
Time in minutes will be calculated for completing the procedure with the Spyglass DS.
Time frame: approximately 2 hours
Population: 83 Spyglass procedures were conducted on the 75 participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cholangioscopy | Measurement of Total Procedure Time Using the Spyglass DS | 64.3 minutes |
Secondary
Number of Cholangioscopic Exams That Detected Ductal Stones
The abnormalities found during the procedure, such as ductal stones.
Time frame: Day 1
Population: 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..
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cholangioscopy | Number of Cholangioscopic Exams That Detected Ductal Stones | 35 exams |
| Pancreatoscopy | Number of Cholangioscopic Exams That Detected Ductal Stones | 2 exams |
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.
Time frame: Day 1
Population: Spyglass-guided stone therapy was attempted in 26 patients with biliary stones
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cholangioscopy | Number of Participants With Successful Removal of the Biliary or Pancreas Stones | 24 participants |
Secondary
Spybite Sampling Attempts Per Procedure
The mean number of attempts per procedure
Time frame: Day 1
Population: Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cholangioscopy | Spybite Sampling Attempts Per Procedure | 3.94 sampling attempts per procedure |
Secondary
Strictures Found During the Procedure Will be Measured
The abnormalities found during the procedure, such as strictures.
Time frame: Day 1
Population: A total of 78 Cholangioscopic examinations were attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cholangioscopy | Strictures Found During the Procedure Will be Measured | 27 strictures found |
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.
Time frame: approximately 2 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cholangioscopy | Time to Set-up the Spyglass DS for the Procedure | 5 minutes |