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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis
National Cheng Kung University Hospital
Tainan, Taiwan
A complete common bile duct accessing rate
To test the device's feasibility
Time frame: 1 day
Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).
Time frame: 1 day
Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
To test the device's safety
Time frame: 1 day
In biliary stone arm: The biggest residual stone size (in cm).
The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)
Time frame: 1 day
In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture
The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.
Time frame: 1 day
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