This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.
It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.
Study Type
OBSERVATIONAL
Enrollment
236
SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGdetection rate
detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy
Time frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Technical success of cholangioscopy
successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree
Time frame: Up to 15 minutes from the time the endoscope passes through the oral cavity
Technical success of cholangioscopy-guided biopsy
successful tissue sampling of intraductal superficial lesions under direct visualization
Time frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Adverse events
all adverse events including cholangitis, pancreatitis, perforation, bleeding, and air embolism based on ASGE criteria
Time frame: From the start of endoscopy to the end of the study observation period (at least 12 months)
Number needed to screen
the number of persons who would need to be screened to diagnose one neoplastic bile duct lesion in selected patients
Time frame: From the start of endoscopy to the end of the study observation period (at least 12 months)
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