Abstract
Background and study aims Cholangiopancreatoscopy is utilized for diagnosis and therapy of pancreaticobiliary
disorders. a fully-disposable, digital, single-operator cholangioscope (DSOC) was
developed with high image resolution and wide field-of-view. This bench study compared
the new DSOC to the previous semi-disposable, fiber-optic cholangioscope (FSOC) prior
to the clinical availability of the DSOC system.
Methods Five experts performed one practice run followed by randomized runs comparing DSOC
to FSOC in a biliary tract model consisting of three fixed left-intrahepatic tracts
(LIHD), and variable common bile duct (CBD) and right-intrahepatic tracts (RIHD) with
seven total lesions in multiple configurations. Timed runs aimed to visualize and
target each lesion using miniature biopsy forceps. Definitions: visual success, visualizing
targets; targeting success, touching target with forceps; complete run, touching seven
targets within 20 minutes. Image quality, ease-of-use, and time to completion were
recorded.
Results Thirty-seven evaluable runs (20 DSOC, 17 FSOC) were completed. DSOC was superior to
FSOC in Visual (99 % vs. 67 %, P < 0.001) and targeting success (6.6 vs. 4.5, P = 0.009), proportion of complete runs (13 /20 vs. 0 /17, P < 0.001) and time of run (10.1 min vs. 15.4 min, P < 0.001). For fixed LIHD, DSOC achieved higher targeting success compared to FSOC
(2.6 vs. 1.1, P < 0.001) with no difference in RIHD and CBD targets (4.0 vs. 3.4, P = 0.39). Investigators reported superior image quality and ease-of-use with DSOC.
Conclusions In this model, DSOC performed superiorly to FSOC in image quality, visualization,
and maneuverability. The model could potentially be utilized for training endoscopists
less experienced with cholangiopancreatoscopy.
