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

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 Overview

• Status: Completed
• Conditions: Neoplasms; Stone - Biliary; Biliary Tract
• Intervention / Treatment: Device: NCKU-scope-01 (a custom-made biliary endoscope system)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: NCKU-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
Experimental: 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.	Device: NCKU-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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: A-BR-108-097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No