Clinical Validation of an Immunocytochemistry Method Using MARS1

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Bile Duct Obstruction, Extrahepatic

Treatments: Diagnostic Test: Cytology staining

Study type: Interventional

Funder types: Other

Identifiers

NCT04759794

3-2020-0514

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 55 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Bile duct stenosis

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Cytology staining