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.).