Diagnostic Value and Safety of Combined Biopsy for Mediastinal Metastasis of Lung Cancer

March 18, 2026 updated by: Ye Fan, Third Military Medical University

Diagnostic Value and Safety of EBUS-TBNA Combined With Medaistinal Cryobiopsy for Mediastinal Metastasis of Lung Cancer

The study is aimed o evaluate the diagnostic performance and treatment guidance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBUS-TBMCB) in patients with mediastinal metastases of lung cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), will serve as control. Enrolled patients will be randomly assigned to two groups: the experimental group, which will undergo EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) following EBUS-TBNA, and control group, which will undergo EBUS-TBNA alone. Biopsy specimens from both groups will be analyzed by pathologists. All patients will be followed up to confirm the diagnosis and to document any complications. The diagnostic yield for lung cancer and the incidence of procedure-related adverse events will be compared between the two groups.

Study Type

Interventional

Enrollment (Estimated)

240

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 Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Recruiting
        • Third Military Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 years;
  2. Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT;
  3. Patients who have not undergone prior mediastinal biopsy and require further mediastinal biopsy to confirm etiology or pathological subtype, meeting at least one of the following criterias:

(1) suspected lung cancer diagnosed by two senior physicians; (2) confirmed lung cancer (requiring mediastinal staging); (3) recurrent lung cancer; 4.Patients must have completed all required preoperative laboratory tests and necessary examinations (e.g., cardiac ultrasound, CTA) to rule out contraindications; 5. Patients are informed and capable of providing written informed consent.

Exclusion Criteria:

  1. Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other contraindications related to bronchoscopy;
  2. Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts;
  3. Lesions identified as abscesses or cysts;
  4. Presence of mental illness, severe neurosis, or other conditions that preclude the provision of informed consent;
  5. Patients who have participated in other clinical trials within 3 months;
  6. Any other conditions considered to be inappropriate to be involved in this trial.

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
Intervention / Treatment
No Intervention: EBUS-TBNA
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be performed
Experimental: EBUS-TBNA plus EBUS-TBMCB
Following the completion of EBUS-TBNA, EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) will be performed.
Procedure: EBUS-TBMCB
Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield for lung cancer
Time Frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
For each biopsy modality, diagnostic yield for lung cancer is defined as the percentage of patients with eventually confirmed lung cancer (by histopathology/cytology or long-term follow-up) in whom the initial biopsy using that modality established the diagnosis.
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Diagnostic accuracy was defined as the proportion of patients whose initial test results are consistent with the final diagnosis, based on histopathological/cytological findings and long-term follow-up assessment
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Sample size
Time Frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
The area and diameter of samples obtained by each procedure
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Suitability for molecular assays
Time Frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Suitability of NSCLC samples for molecular assays
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Duration of bronchoscopic procedure
Time Frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
The duration of each specific step from the start to the end of the biopsy
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Incidence of procedure-related adverse events
Time Frame: Within 30 days post-biopsy
The ratio of the number of patients who had adverse events caused by the procedures and the number of all patients who have undergone EBUS procedures in each arm
Within 30 days post-biopsy

Collaborators and Investigators

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

Sponsor

Third Military Medical University

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 (Estimated)

March 20, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-Research No. 038-02

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.

Clinical Trials on Mediastinal Metastases of Lung Cancer

Clinical Trials on EBUS-TBMCB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe