Bile Duct Diseases, Bile Duct Obstruction, Pancreatic Diseases
Conditions
Keywords
Percutaneous transhepatic cholangiopancreatoscopy, spyglass discover, pancreaticobiliary disease
Brief summary
To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
Detailed description
This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to: * PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy, * PTCS for stone removal after surgically or pathologically-altered anatomy, * Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation, * Percutaneous delivery of palliative intraluminal brachytherapy, * Intra-procedural percutaneous salvage procedures when an initial route of access fails
Interventions
DEVICESpyGlass™ Discover Digital System
Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice 2. Written informed consent from patient or legally authorized representative of the patient
Exclusion criteria
1. Contraindication for cholangiopancreatoscopy 2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access 3. \<18 years of age 4. Potentially vulnerable subjects, including, but not limited to pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieving clinical intent of procedure as indicated | 1 month | Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | During index procedure | Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target |
| Procedural Time | During index procedure | Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter |
| Number of PTCS procedures | 1 month | Number of PTCS procedures required to achieve clinical success until the end of follow-up |
| Endoscopist rating | During index procedure | Endoscopist rating of the following attributes when using SpyGlass™ Discover Digital Catheter compared to marketed reusable scopes Ability to complete the procedure Ability to retroflex Ability to selectively advance into targeted ducts Ability to obtain targeted biopsies Ability to grasp stones Ability to guide lithotripsy Ability to suction Ability to irrigate Ability to advance accessories through scope channel Image quality |
| Number of Adverse Events | 1 month | Serious adverse events related to the study device, accessory devices used through the working channel of the SpyGlass™ Discover Digital Catheter or the cholangiopancreatoscopy portion of the PTCS procedure(s). |
Countries
Belgium, Canada, Germany, Hong Kong, India, Italy, United States
Outcome results
None listed