Using a new cholangioscopy system to screen for bile duct cancer
Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones
This study is testing a new tool called the SpyGlass DS II to see if it can help find early signs of bile duct cancer in patients who are at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 236 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Soonchunhyang University Hospital Academic / other |
| Locations | 1 site (Bucheon, Gyeonggi-do) |
| Trial ID | NCT05600803 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the SpyGlass DS II system for screening early-stage neoplastic bile duct lesions in patients with risk factors for cholangiocarcinoma. Traditional imaging methods like CT and MRI often fail to provide tissue diagnoses, while ERCP has limited diagnostic accuracy. The SpyGlass system allows for single-operator cholangioscopy, which may improve the detection of these lesions during ERCP procedures. The study will focus on patients with dilated common bile ducts who are undergoing ERCP for confirmation of CBD clearance.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific risk factors for cholangiocarcinoma who are undergoing ERCP.
Not a fit: Patients with existing biliary tract cancer or those with contraindications for ERCP may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of bile duct cancers, improving patient outcomes.
How similar studies have performed: While cholangioscopy has been explored in other studies, the specific use of the SpyGlass DS II system for this purpose is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bucheon, Gyeonggi-do
- Soonchunhyang University Bucheon Hospital — Bucheon, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jong Ho Moon, MD,PhD,FASGE,FJGES
- Email: jhmoonsch@gmail.com
- Phone: +82-32-62-5094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.