CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(07): E851-E856
DOI: 10.1055/a-0584-6458
Original article
Owner and Copyright © Georg Thieme Verlag KG 2018

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

Raj J. Shah
Gastroenterology, University of Colorado, Aurora, Colorado, United States
,
Horst Neuhaus
Gastroenterology, Evangelisches Krankenhaus, Dusseldorf, Dusseldorf, Germany
,
Mansour Parsi
Gastroenterology, Cleveland Clinic Foundation, Cleveland, United States
,
D. Nageshwar Reddy
Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
,
Douglas K. Pleskow
Gastroenterology, Beth Israel Deaconess Medical Center, Boston, United States
› Author Affiliations
Further Information

Publication History

submitted 22 July 2017

accepted after revision 27 December 2017

Publication Date:
04 July 2018 (online)

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.