Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer

Not Applicable

Completed

• Conditions: Bile Duct Obstruction, Extrahepatic
• Interventions: Diagnostic Test: Cytology staining

• Registration Number: NCT03708445
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-14
• Study First Posted: 2018-10-17
• Study Start: 2018-11-01
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-02
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bile duct stenosis	Cytology staining	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.

Primary Outcome Measures

Name	Time	Method
The usefulness of new staining method	1 year	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.

Trial Locations

Locations (6)

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