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Trial Title:
Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions
NCT ID:
NCT05600803
Condition:
Cholangiocarcinoma
Bile Duct Neoplasms
Conditions: Official terms:
Cholangiocarcinoma
Bile Duct Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Single-operator cholangioscopy
Description:
SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization
of the pancreaticobiliary system for the evaluation of intraductal lesions
Arm group label:
DSOC group
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.
Criteria for eligibility:
Study pop:
We plan to recruit a total of 239 patients, assuming that the detection rate of
neoplastic bile duct is about 3.5% by referring to the preceding literature. (one-sample
inference for binomial proportions, one-sided test, significance 5%, power 80%)
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
19 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Soonchunhyang University Bucheon Hospital
Address:
City:
Bucheon
Zip:
14584
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jong Ho Moon, MD, PhD, FASGE, FJGES
Phone:
+82-32-621-5094
Email:
jhmoonsch@gmail.com
Contact backup:
Last name:
Il Sang Shin, MD, PhD
Phone:
+82-32-62-5094
Email:
110554@schmc.ac.kr
Start date:
October 30, 2022
Completion date:
October 30, 2025
Lead sponsor:
Agency:
Soonchunhyang University Hospital
Agency class:
Other
Source:
Soonchunhyang University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600803
