Status:
COMPLETED
Clinical Validation of an Immunocytochemistry Method Using MARS1
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Bile Duct Obstruction, Extrahepatic
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of...
Detailed Description
Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograd...
Eligibility Criteria
Inclusion
- Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
- Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
- Patients who underwent surgical treatment with biliary cancer
- Patients with bile duct stenosis
Exclusion
- Minors under the age of 19, vulnerable subjects such as illiteracy
- Necrotic specimens
- Samples with non-diagnostic cytology results and insufficient cells for further evaluation
- Samples classified as neoplastic (benign or other)
- Patient with cholangitis in the bile duct
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04759794
Start Date
February 4 2021
End Date
February 3 2023
Last Update
March 13 2025
Active Locations (5)
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1
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea, 13496
2
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea, 06229
3
In Ha University Hospital
Incheon, Jung-gu, South Korea, 22332
4
Soon Chun Hyang University Hospital, Cheonan
Cheonan, Namdong-gu, South Korea, 31151