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.

Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.

Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.

The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis

To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).

The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)

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.

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.).