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Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02967926
Enrollment
51
Registered
2016-11-18
Start date
2015-12-31
Completion date
2016-11-30
Last updated
2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

common bile duct stone, cholangioscopy, SpyGlass, non-fluoroscopic

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREEndoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)

Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

Sponsors

Boston Scientific Corporation
CollaboratorINDUSTRY
Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal1 year

Secondary

MeasureTime frame
Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal1 year

Other

MeasureTime frame
Procedural time1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026