Disorders of the Pancreas and Biliary Tree
Conditions
Brief 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.
Interventions
OTHERERCP as per medical indication
ERCP as per medical indication
Sponsors
University of Florida
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 years or older. * Scheduled to undergo ERCP with cholangioscopy and/or pancreatoscopy at the University of Florida, Gainesville, FL as medically indicated. * Subject must be able to give informed consent
Exclusion criteria
* Any contraindication to ERCP. * The subject is unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Procedure Completion | baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
There were 88 participants who were enrolled into the study; however, 13 were excluded because they did not qualify for the SpyGlass examination.
Participants by arm
| Arm | Count |
|---|---|
| ERCP With Cholangioscopy and/or Pancretoscopy Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | SpyGlass Failed | 5 |
Baseline characteristics
| Characteristic | ERCP With Cholangioscopy and/or Pancretoscopy |
|---|---|
| Age, Continuous | 66 years |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
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.
Time frame: baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ERCP With Cholangioscopy and/or Pancretoscopy | Successful Procedure Completion | Successful completion | 70 participants |
| ERCP With Cholangioscopy and/or Pancretoscopy | Successful Procedure Completion | Unsuccessful/Failed | 5 participants |