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

April 26, 2016 updated by: Chen Liang_An, Chinese PLA General Hospital
The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100863
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: endobronchial ultrasound elastography
Before endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elastography strain ratio
Time Frame: six months
Elastography strain ratios were calculated between selected area of the lesions and the surrounding normal tissues.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of strain ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
six months
Elasticity score
Time Frame: six months
Elasticity scores were obtained by analyzing elastography images.Scores:1-2: benign;3-4: malignant lesions. The sensitivity and specificity of elastography for the diagnosis of malignant thoracic lesions were calculated on the basis of above-specified criteria. The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
six months
Elastography area ratio
Time Frame: six months
Elastography area ratios were defined as following:areas as blue pixels/lesion areas as region of interest pixels.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of area ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of value of endobronchial ultrasound elastography in differentiated diagnosis of thoracic lesions with that of conventional ultrasound.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Liang-an Chen, MD,PHD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2016-020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Because of personal privacy, the research-related individual participant data do not intend for public sharing.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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