Bile Duct Neoplasms, Cholangiocarcinoma
Conditions
Brief summary
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
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.
Interventions
PROCEDURESingle-operator cholangioscopy
SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions
Sponsors
Soonchunhyang University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged \> 18 years 2. Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins) 3. Patients who undergo ERCP for confirmation of CBD clearance 4. Dilated common bile duct (\> 10 mm) 5. Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation
Exclusion criteria
1. Presence of biliary tract cancer 2. Presence of distal CBD stricture 3. Bleeding tendency (INR\>1.5 or platelets \<50000 mm3) 4. Contraindications of ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| detection rate | Until the end of the single-operator cholangioscopy session (up to 20 minutes) | detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of cholangioscopy | Up to 15 minutes from the time the endoscope passes through the oral cavity | successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree |
| Technical success of cholangioscopy-guided biopsy | Until the end of the single-operator cholangioscopy session (up to 20 minutes) | successful tissue sampling of intraductal superficial lesions under direct visualization |
| Adverse events | From the start of endoscopy to the end of the study observation period (at least 12 months) | all adverse events including cholangitis, pancreatitis, perforation, bleeding, and air embolism based on ASGE criteria |
| Number needed to screen | From the start of endoscopy to the end of the study observation period (at least 12 months) | the number of persons who would need to be screened to diagnose one neoplastic bile duct lesion in selected patients |
Countries
South Korea
Contacts
Primary ContactJong Ho Moon, MD,PhD,FASGE,FJGES
Backup ContactIl Sang Shin, MD,PhD
Outcome results
None listed