MedDataX Logo

Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions

NCT ID: NCT02755506

Last Updated: 2016-04-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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

The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions

Detailed Description

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

Ultrasound elastography has been gradually used in clinic with the rapid development of ultrasonic technique,and presents a promising application prospect in differentiated diagnosis of benign and malignant disease.The aim of the study is to evaluate the accuracy of endobronchial ultrasound elastography in the diagnosis of thoracic lesions.

Conventional ultrasound and ultrasound elastography are respectively used to examine thoracic lesions before aspiration,then the images are saved as video clips. Features of conventional ultrasound and parameters of ultrasound elastography are analysed and recorded by skilled worker. The investigators define the pathological results of EBUS-TBNA combined with results of six months follow-up as the "Gold Standard". The receiver operator characteristic curves are drawn to obtain area under the Curve (AUC) and the best diagnostic threshold values of each parameters. According to the best cutoff values, the investigators respectively calculate the accuracy, sensitivity, specificity, odds product of each parameters, and then compare them with each other to evaluate the value of ultrasound elastography

Conditions

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

Thoracic Lesions

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ultrasound elastography Thoracic lesions EBUS-TBNA

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

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.

patients with thoracic lesions

Patients with thoracic lesions is going to undergo endobronchial ultrasound elastography followed by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).

Group Type EXPERIMENTAL

endobronchial ultrasound elastography

Intervention Type DEVICE

Before endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography

Interventions

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

endobronchial ultrasound elastography

Before endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Hilar/mediastinal lymph lesions with a short axis more than 1 cm on thoracic computed tomography( CT) scan and/or positron emission tomography-computed tomography (PET-CT)
* With normal Coagulation function
* With normal cardio pulmonary function and be able to tolerate bronchoscopy
* No syphilis,acquired immune deficiency syndrome(AIDS) and other infectious diseases
* Willing and able to give written informed consent

Exclusion Criteria

* Unable to lie in bed
* Allergy to narcotics such as lidocaine.
* Suffering from cardiovascular and cerebrovascular disease, severe lung liver and kidney dysfunction, or after drug treatment cannot maintain the normal.
* With abnormal Coagulation function or take anticoagulant drugs within the previous week.
* Hematological abnormalities, fever or highly suspected active tuberculosis patients.
* Women in the menstrual period.
* Excessive anxiety and can not tolerate bronchoscopy.
* Other conditions that are not suitable for inclusion in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chen Liang_An

Director of respiratory medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liang-an Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S2016-020-01

Identifier Type: -

Identifier Source: org_study_id