Transparent Cap-assisted SpyGlass for Biliary Stricture

Study Overview
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Brief Summary
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The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.

Detailed Description
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Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.

Official Title
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Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture

Conditions
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Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography, Biliary Disease, Biliary Tract Neoplasms

Intervention / Treatment
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* Device: Transparent cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The indications for ERCP. Written informed consent Exclusion Criteria: Underlying bleeding disorder The platelet count less than 50×10^9/L Serious cardio-pulmonary, hepatic or renal disease Intolerance to ERCP Other high-risk conditions or disease (such as massive ascites, etc.) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transparent cap-assisted SpyGlass<br>Add a transparent cap to the end of the SpyGlass choledochoscopy | Device: Transparent cap<br>* Add a self-made transparent cap (made by cutting a silicone drainage tube) to the end of the SpyGlass choledochoscope, and then perform routine choledochoscopy and biopsy operations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clearness of visual field | The clearness of visual field was evaluated by the operating physician and was rated as clear or not clear. | Immediately | 
| Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations | Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass | Immediately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy accuracy | Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile Duct Stricture, ERCP, Choledochoscopy, Transparent Cap, Biliary biopsy