Biliary and pancreatic diseases in need of cholangiopancreatoscopy diagnosis and treatment
Conditions
Interventions
Cholangiopancreatoscopy diagnosis and treatment using the Spyglass DS
Sponsors
Tokyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20 or older 2. Willing and able to provide written informed consentto participate in the study 3. Willing and able to comply with the study procedures 4. Indicated for ERCP and cholangioscopy or indicated forERCP with suspected need for cholangioscopy
Exclusion criteria
Exclusion criteria: 1. Endoscopic techniques are contraindicated 2. ERCP is contraindicated 3. Requirement for anticoagulation that cannot be safely stopped 4. Other, the patients deemed unsuitable for carrying out the present study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. SpyGlass DS procedural success rate 2. Evaluation of serious adverse events (SAEs) related to the SpyGlass DS devices and/or the SpyGlass DS procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time of SpyGlass DS procedure and ERCP procedure 2. Visible region of biliary duct or pancreatic duct using SpyGlass DS 3. Impact of SpyGlass DS procedure on patient management 4. Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure 5. Diagnostic accuracy of SpyBite histopathology 6. Efficacy of SpyGlass DS procedure for stone management | — |
Countries
Japan
Contacts
Public ContactTakao Itoi
Tokyo Medical University Department of Gastroenterology a nd Hepatology
Outcome results
None listed