Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- A complete common bile duct accessing rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.).
Arms & Interventions
Biliary stone
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.
Intervention: NCKU-scope-01 (a custom-made biliary endoscope system) (Device)
Biliary stricture
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.
Intervention: NCKU-scope-01 (a custom-made biliary endoscope system) (Device)
Outcomes
Primary Outcomes
A complete common bile duct accessing rate
Time Frame: 1 day
To test the device's feasibility
Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
Time Frame: 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 Outcomes
- Number of complications (ablation, bleeding, perforation in percentage) or system malfunction(1 day)
- In biliary stone arm: The biggest residual stone size (in cm).(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(1 day)
Investigators
Chiao-Hsiung Chuang
Associate Professor
National Cheng-Kung University Hospital