Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
Primary Purpose
Common Bile Duct Diseases, Stone - Biliary, Cholangitis, Sclerosing
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Diseases focused on measuring common bile duct stone, cholangioscopy, SpyGlass, non-fluoroscopic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ERCP without Fluoroscopy
Arm Description
Non-fluoroscopic common bile duct stone extraction
Outcomes
Primary Outcome Measures
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
Secondary Outcome Measures
Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
Full Information
NCT ID
NCT02967926
First Posted
November 3, 2016
Last Updated
November 16, 2016
Sponsor
Chulalongkorn University
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02967926
Brief Title
Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
Official Title
Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Diseases, Stone - Biliary, Cholangitis, Sclerosing
Keywords
common bile duct stone, cholangioscopy, SpyGlass, non-fluoroscopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERCP without Fluoroscopy
Arm Type
Experimental
Arm Description
Non-fluoroscopic common bile duct stone extraction
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
Intervention Description
Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal
Primary Outcome Measure Information:
Title
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Procedural time
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
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