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

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03708445

Collaborator

Korea Institute of Science and Technology (Other)

240

Enrollment

Locations

Arm

14.7

Actual Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bile Duct Obstruction, Extrahepatic	Diagnostic Test: Cytology staining	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jan 22, 2020

Actual Study Completion Date :

Jan 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bile duct stenosis 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 Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography conventional cytology staining method new cytology staining method using antibody of aminoacyl-tRNA synthetases

Arm

Intervention/Treatment

Experimental: Bile duct stenosis

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

Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography conventional cytology staining method new cytology staining method using antibody of aminoacyl-tRNA synthetases

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA Bundang Medical Center	Seongnam	Bundang-gu	Korea, Republic of	13496
2	Gangnam Severance Hospital	Seoul	Gangnam-gu	Korea, Republic of	06229
3	In Ha University Hospital	Incheon	Jung-gu	Korea, Republic of	22332
4	Soon Chun Hyang University Hospital, Cheonan	Cheonan	Namdong-gu	Korea, Republic of	31151
5	Gachon University Gil Medical Center	Incheon	Namdong-gu	Korea, Republic of	21565
6	Pusan National University Hospital	Busan-si	Seo-gu	Korea, Republic of	49241