Bile Duct Diseases, Hepatic Disease, Pancreatic Diseases
Conditions
Brief summary
* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope * To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
Detailed description
This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to: * Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy * Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy * Treatment of hepatolithiasis * Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses * Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy * Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy
Interventions
DEVICESpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy 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
* Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope * Written informed consent from patient or legally authorized representative of the patient
Exclusion criteria
* Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope * \<18 years of age * Potentially vulnerable subjects, including, but not limited to pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | During study procedure | Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to: * Direct visualization of target lesion or stricture * Obtaining biopsies * Initiating and/or completing stone clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 1 month | Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure |
| Endoscopist rating of clinical impact of study procedure | During study procedure | Characterization and rating of the clinical benefit and impact of intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope to the surgical procedure on a 1 (highly dissatisfied) to 10 (highly satisfied) scale |
| Adequate diagnostic yield | 1 month | Adequate diagnostic yield of tissue biopsy for histopathology assessment |
| Endoscopist rating of device | During study procedure | Rating of the intraoperative performance of the SpyGlass™ system and accessories during intraoperative endoscopy procedure compared to marketed reusable endoscopes on a 1 (highly dissatisfied) to 10 (highly satisfied) scale: 1. Image quality 2. Ability to irrigate field of view through the irrigation channels 3. Ability to aspirate through the working channel 4. Ability to retroflex 5. Ability to obtain targeted biopsies using biopsy forceps 6. Ability to grasp stones using wire basket 7. Ability to perform lithotripsy 8. Ability to advance accessories through catheter 9. Ability to selectively advance into targeted ducts |
Countries
China, Hong Kong, India, United States
Outcome results
None listed