NCT03708445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

October 14, 2018

Last Update Submit

February 2, 2020

Conditions

Bile Duct Obstruction, Extrahepatic

Keywords

bile duct obstruction, extrahepaticcytologyaminoacyl-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 stainingDIAGNOSTIC_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

Bile duct stenosis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

Related Publications (1)

  • Jang SI, Nahm JH, Kwon NH, Jeong S, Lee TH, Cho JH, Kwon CI, Kim DU, Kim JM, Cho HD, Lee HS, Kim S, Lee DK. Clinical utility of methionyl-tRNA synthetase 1 immunostaining in cytologic brushings of indeterminate biliary strictures: a multicenter prospective study. Gastrointest Endosc. 2021 Oct;94(4):733-741.e4. doi: 10.1016/j.gie.2021.04.026. Epub 2021 May 6.

    PMID: 33965384DERIVED

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • 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
Model Details: The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, MD, PhD

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 17, 2018

Study Start

November 1, 2018

Primary Completion

January 22, 2020

Study Completion

January 22, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

We plan to share the following individual participant data with other researchers during study period. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 year
Access Criteria
* Primary investigator * Sub primary investigator

Locations

KR(6)