Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

Recruiting

• Conditions: Bile Duct Neoplasms; Cholangiocarcinoma
• Interventions: Procedure: Single-operator cholangioscopy

• Registration Number: NCT05600803
• Lead Sponsor: Soonchunhyang University Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study Start: 2022-10-30
• Study First Posted: 2022-11-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DSOC group	Single-operator cholangioscopy	Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of