Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

Soon Chun Hyang University

Status: Enrolling

Conditions: Bile Duct Neoplasms; Cholangiocarcinoma

Treatments: Procedure: Single-operator cholangioscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05600803

screeningsoc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

236 participants in 1 patient group

DSOC group

Description:

Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy.

Treatment:

Procedure: Single-operator cholangioscopy