Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: null- Patients with very different distribution of bile duct diseases, such as biliary strictures, biliary obstructions due to common bile duct stone, periampullary tumors, and Hemobilia.
Conditions
Interventions
Intervention1: SpyGlassâ?¢ Direct Visualization System (DVS): The SpyGlass Direct Visualization System is made up of the following devices:
SpyScopeâ?¢ Access and Delivery Catheter is intended to guid
Sponsors
Boston Scientific Corporation
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent to participate in the study. Willing and able to comply with the study procedures. Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.
Exclusion criteria
Exclusion criteria: 1.Endoscopic techniques are contraindicated. 2.ERCP is contraindicated 3.A medical condition that warrants the use of the device outside of the indication for use. 4.Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural Success 1.Indeterminate strictures: 1) ability to visualize stricture or defect 2) ability to provide visual impression of malignancy 3) when applicable, ability to obtain SpyBite biopsy adequate for histology 2.Biliary stones cases: 1) ability to visualize stones 2) ability to successfully initiate stone fragmentation 3) ability to achieve stone clearance in one or more SpyGlass procedures. 3.Other Indications: ability to establish diagnosis and /or complete therapy Timepoint: Procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit.Timepoint: 72 Hour Post Procedure Follow-up Visit;10.For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.Timepoint: Procedure;11.For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.Timepoint: Procedure;2.Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP.Timepoint: Procedure;3.Impact of SpyGlass procedure on patient management.Timepoint: Procedure;4.Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.Timepoint: Up to 6 Months Post Procedure;5.For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.Timepoint: Up to 6 Months Post Procedure;6.For patients undergoing SpyBite biopsy: correlation between SpyGlass visual impression of malignancy and SpyBite histopathology.Timepoint: Up to 6 Months Post Procedure;7.For patients undergoing SpyBite biopsy: diagnostic accuracy of SpyGlass visual impression of malignancy and SpyBite histopathology based on reported incidence of malignancy at 6 months of follow-up.Timepoint: Up to 6 Months Post Procedure;8.For patients undergoing SpyBite biopsy: correlation between SpyBite histopathology and observed image features.Timepoint: Procedure;9.For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.Timepoint: Procedure | — |
Countries
Australia, Hong Kong, India, Japan, Pakistan, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand
Contacts
Public ContactDr Mohan Ramchandani
Asian Institute of Gastroenterology
Outcome results
None listed