Clinical Validation of an Immunocytochemistry Method Using MARS1

Study Overview
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Brief Summary
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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 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
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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 a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunocytochemistry 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.

Official Title
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Clinical Validation of an Immunocytochemistry Method Using Antibody of Methionyl-tRNA Synthetase (MARS1) in the Bile Duct Cancer Cell; Multicenter Study

Conditions
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Bile Duct Obstruction, Extrahepatic

Intervention / Treatment
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* Diagnostic Test: Cytology staining


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The conventional staining method and new staining method will be performed in cytology specimens obtained from the same patient.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bile duct stenosis<br>This arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens. | Diagnostic Test: Cytology staining<br>* Two stainings will be performed in cytology specimens obtained from the same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography conventional cytology staining method new cytology staining method using the antibody of aminoacyl-tRNA synthetases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The usefulness of new staining method | The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bile duct obstruction, extrahepatic, cytology, aminoacyl-tRNA synthetases