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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biliary stone | Experimental | 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. |
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| Biliary stricture | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCKU-scope-01 (a custom-made biliary endoscope system) | Device | The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D041761 | Cholecystolithiasis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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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 |