* 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
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
Study Type
OBSERVATIONAL
Enrollment
34
Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.
Indiana University Health
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Lanzhou University No. 1 Hospital
Lanzhou, Gansu, China
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Technical success
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
Time frame: During study procedure
Number of adverse events
Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure
Time frame: 1 month
Endoscopist rating of clinical impact of 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
Time frame: During study procedure
Adequate diagnostic yield
Adequate diagnostic yield of tissue biopsy for histopathology assessment
Time frame: 1 month
Endoscopist rating of device
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
Time frame: During study procedure
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Asian Institute of Gastroenterology
Hyderabad, Telangana, India