Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct
 stone or neoplasm. This system consists of a camera, light sources, a working channel, and a
 water injection channel. The endoscope could be inserted into the common bile duct via the
 working channel of a commercial duodenoscope. This study aims to test the feasibility and
 safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.
Inclusion Criteria:

 -  Patients with complicated bile duct stone (stone size > 1.5 cm or number of stone > 3
 )

 -  Patients with indeterminate biliary stricture or obstruction

 Exclusion Criteria:

 -  Pregnant woman;

 -  Patients who are not suitable for ERCP (e.g. behavior disorder, major
 cognitive-perceptual deficit, etc.).