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OpenTrials
Completed

NCT Number: NCT02967926

Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)

Procedure

Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

Primary outcomes

  1. Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

    Time frame: 1 year

Secondary outcomes

  1. Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

    Time frame: 1 year

Other outcomes

  1. Procedural time

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2016
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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