Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones

Conditions
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Cholangiocarcinoma, Bile Duct Neoplasms

Intervention / Treatment
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* Procedure: Single-operator cholangioscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged > 18 years Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins) Patients who undergo ERCP for confirmation of CBD clearance Dilated common bile duct (> 10 mm) Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation Exclusion Criteria: Presence of biliary tract cancer Presence of distal CBD stricture Bleeding tendency (INR>1.5 or platelets <50000 mm3) Contraindications of ERCP

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DSOC group<br>Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy. | Procedure: Single-operator cholangioscopy<br>* SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate | detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy | Until the end of the single-operator cholangioscopy session (up to 20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of cholangioscopy | successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree | 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 | 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 | 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 | From the start of endoscopy to the end of the study observation period (at least 12 months) |