Randomized study of digital single-operator cholangioscope compared to fiberoptic single-operator cholangioscope in a novel cholangioscopy bench model

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.