Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Diseases
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Achieving clinical intent of procedure as indicated
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Written informed consent from patient or legally authorized representative of the patient
Exclusion Criteria
- •Contraindication for cholangiopancreatoscopy
- •Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
- •\<18 years of age
- •Potentially vulnerable subjects, including, but not limited to pregnant women
Outcomes
Primary Outcomes
Achieving clinical intent of procedure as indicated
Time Frame: 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 Outcomes
- Number of Adverse Events(1 month)
- Technical success(During index procedure)
- Procedural Time(During index procedure)
- Endoscopist rating(During index procedure)
- Number of PTCS procedures(1 month)