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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnosis of Bile Duct Strictures

NCT02000999

Bile Duct Stricture Cholangiocarcinoma Pancreatic Cancer +1 more

COMPLETED

Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy

NCT02189421

Common Bile Duct Calculi Biliary Tract Cancer Biliary Stricture +1 more

UNKNOWN NA

Intestinal Metaplasia Cohort for Gastric Cancer Prediction

NCT06075199

Intestinal Metaplasia of Gastric Mucosa

RECRUITING

Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma

NCT05993429

Klatskin Tumor Cholangiocarcinoma Biopsy, Fine-Needle +1 more

RECRUITING

Comparison of Biliary Forceps Biopsy and Brush Cytology

NCT01145248

Cholangiocarcinoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bile Duct Obstruction, Extrahepatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cytology staining

Intervention Type DIAGNOSTIC_TEST

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

1. conventional cytology staining method
2. new cytology staining method using antibody of aminoacyl-tRNA synthetases

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

1. conventional cytology staining method
2. new cytology staining method using antibody of aminoacyl-tRNA synthetases

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No