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Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02967926
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Boston Scientific Corporation
Information provided by (Responsible Party):
Thanawat Luangsukrerk, Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Common Bile Duct Diseases Stone - Biliary Cholangitis, Sclerosing Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
Study Start Date : December 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: ERCP without Fluoroscopy
Non-fluoroscopic common bile duct stone extraction
Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

Primary Outcome Measures :
  1. Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Procedural time [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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
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Responsible Party: Thanawat Luangsukrerk, Gastrointestinal Endoscopy Excellence Center, Chulalongkorn University Identifier: NCT02967926    
Other Study ID Numbers: 791/2016
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Thanawat Luangsukrerk, Chulalongkorn University:
common bile duct stone
Additional relevant MeSH terms:
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Bile Duct Diseases
Cholangitis, Sclerosing
Common Bile Duct Diseases
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases