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

Not Applicable

Completed

• Conditions: Stone - Biliary; Biliary Tract; Neoplasms
• Interventions: Device: NCKU-scope-01 (a custom-made biliary endoscope system)

• Registration Number: NCT04456218
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-29
• Study Start: 2020-07-01
• Study First Posted: 2020-07-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biliary stricture	NCKU-scope-01 (a custom-made biliary endoscope system)	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.
Biliary stone	NCKU-scope-01 (a custom-made biliary endoscope system)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan