Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
NCT ID: NCT02967926
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
51 participants
INTERVENTIONAL
2015-12-31
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ERCP without Fluoroscopy
Non-fluoroscopic common bile duct stone extraction
Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal
Interventions
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Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal
Eligibility Criteria
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Inclusion Criteria
* CBD caliber 5-15 mm
Exclusion Criteria
* History of bile duct tumor
* History of bile duct stricture
* Severe comorbidity
* Unstable vital signs
* Pregnancy
* Coagulopathy
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Chulalongkorn University
OTHER
Responsible Party
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Thanawat Luangsukrerk
Gastrointestinal Endoscopy Excellence Center
Other Identifiers
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791/2016
Identifier Type: -
Identifier Source: org_study_id