Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract

Conditions
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Biliary Tract, Neoplasms, Stone - Biliary

Intervention / Treatment
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* Device: NCKU-scope-01 (a custom-made biliary endoscope system)


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biliary stone<br>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. | Device: NCKU-scope-01 (a custom-made biliary endoscope system)<br>* The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis<br>|
| Experimental: Biliary stricture<br>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. | Device: NCKU-scope-01 (a custom-made biliary endoscope system)<br>* The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A complete common bile duct accessing rate | To test the device's feasibility | 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). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications (ablation, bleeding, perforation in percentage) or system malfunction | To test the device's safety | 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) | 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. | 1 day |