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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
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 3, 2016
    Last Updated
    November 16, 2016
    Sponsor
    Chulalongkorn University
    Collaborators
    Boston Scientific Corporation
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    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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