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Brief Title: Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer
Official Title: Development of a New Immunochemistry Method Using Antibodies of Aminoacyl-tRNA Synthetases Group and Aminoacyl-transfer Ribonucleic Acid Synthetases-interacting Multifunctional protein2 Lacking Exon 2 in the Bile Duct Cancer Cell; Multicenter Study
Study ID: NCT03708445
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 develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer related protein expressed only in bile duct cancer.
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 retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method. Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHA Bundang Medical Center, Seongnam, Bundang-gu, Korea, Republic of
Gangnam Severance Hospital, Seoul, Gangnam-gu, Korea, Republic of
In Ha University Hospital, Incheon, Jung-gu, Korea, Republic of
Soon Chun Hyang University Hospital, Cheonan, Cheonan, Namdong-gu, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Namdong-gu, Korea, Republic of
Pusan National University Hospital, Busan-si, Seo-gu, Korea, Republic of
Name: Institutional Review Board
Affiliation: Gangnam Severance Hospital, Yonsei University College of Medicine
Role: STUDY_CHAIR