Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Study Overview
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Brief Summary
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This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

Detailed Description
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Patients This study recruited patients who suspected/confirmed CBDS from clinical manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (US), computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS). The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All patients were informed and wrote informed consent for the procedure. Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. After identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. Successful cannulation confirmed by visualized bile aspiration. If the patients had difficult cannulation, double guidewire technique was used. After the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to hilum then the investigators sweep until suspected complete CBD clearance. After that the investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.

Official Title
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Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Conditions
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Common Bile Duct Diseases, Stone - Biliary, Cholangitis, Sclerosing

Intervention / Treatment
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* Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinically suspected/confirmed CBDS CBD caliber 5-15 mm Exclusion Criteria: History of bile duct surgery History of bile duct tumor History of bile duct stricture Severe comorbidity Unstable vital signs Pregnancy Coagulopathy

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP without Fluoroscopy<br>Non-fluoroscopic common bile duct stone extraction | Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)<br>* Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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common bile duct stone, cholangioscopy, SpyGlass, non-fluoroscopic