Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions

October 8, 2022 updated by: Ye Fan, Third Military Medical University

The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions

The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
271

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • The Army Medical University
  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany
        • Thoraxklinik - Heidelberg University 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >=15 years;
  • More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT;
  • Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
  • Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
  • Informed consent form achievement.

Exclusion Criteria:

  • Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
  • Failure to detect the mediastinal lesions in ultrasonic landscape;
  • Cysts or abscess;
  • Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
  • Psychiatric disorders or severe neurosis.
  • Participation in other clinical experiments in recent 3 months;
  • Any other conditions considered to be inappropriate to be involved in this 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EBUS-TBNA-TBMCB
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB)
Procedure: EBUS-TBMCB
endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA
No Intervention: EBUS-TBNA
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
diagnostic yield
Time Frame: through study completion, an average of 1 year
percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
through study completion, an average of 1 year
prevalence of the procedure-related adverse events
Time Frame: through study completion, an average of 1 year
the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sample size
Time Frame: through study completion, an average of 1 year
the area and diameter of sample obtained by each procedure
through study completion, an average of 1 year
consumed time
Time Frame: through study completion, an average of 1 year
duration of each period in each procedure
through study completion, an average of 1 year
sample adequacy
Time Frame: through study completion, an average of 1 year
the ratio of the number of patients with adequate sample by the procedure and the number of all the patients who have undergone this procedure
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Military Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heidelberg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ye Fan, PhD, Third Military Medical University
  • Principal Investigator: Felix Herth, Thoraxklinik - Heidelberg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBUS-TBMCB 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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