Clinical Validation of an Immunocytochemistry Method Using MARS1

NCT04759794 | Completed DMC

• 1 other identifier: 3-2020-0514
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Bile Duct Obstruction, Extrahepatic

Keywords

bile duct obstruction, extrahepatic; cytology; aminoacyl-tRNA synthetases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bile duct stenosis

EXPERIMENTAL

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

Interventions

Cytology staining DIAGNOSTIC_TEST

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

Bile duct stenosis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (5)

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13496, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06229, South Korea

Location

In Ha University Hospital

Incheon, Jung-gu, 22332, South Korea

Location

Soon Chun Hyang University Hospital, Cheonan

Cheonan, Namdong-gu, 31151, South Korea

Location

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Sung Ill Jang, MD, PhD

  Institutional Review Board, Gangnam Severance Hospital Yonsei University College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

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

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 4, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: * Primary investigator * Sub primary investigator

Locations

KR (5)