Biliary Tract, Neoplasms, Stone - Biliary
Conditions
Brief summary
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.
Interventions
DEVICENCKU-scope-01 (a custom-made biliary endoscope system)
The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A complete common bile duct accessing rate | 1 day | To test the device's feasibility |
| Image quality evaluation: the light brightness and the imaging sharpness in Likert scale | 1 day | To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of complications (ablation, bleeding, perforation in percentage) or system malfunction | 1 day | To test the device's safety |
| In biliary stone arm: The biggest residual stone size (in cm). | 1 day | 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 | 1 day | 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. |
Countries
Taiwan
Outcome results
None listed