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

NCT07488507 | Recruiting

• 1 other identifier: 2026-Research No. 038-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mediastinal Metastases of Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield for lung cancer

  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 Outcomes (5)

• Diagnostic accuracy

  From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

• Sample size

  From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

• Suitability for molecular assays

  From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

• Duration of bronchoscopic procedure

  From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

• Incidence of procedure-related adverse events

  Within 30 days post-biopsy

Study Arms (2)

EBUS-TBNA

NO INTERVENTION

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be performed

EBUS-TBNA plus EBUS-TBMCB

EXPERIMENTAL

Following the completion of EBUS-TBNA, EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) will be performed.

Procedure: EBUS-TBMCB

Interventions

EBUS-TBMCB PROCEDURE

Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA

EBUS-TBNA plus EBUS-TBMCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years;
• Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Central Study Contacts

Hanbing Wang

CONTACT

+86 18885230175; 18885230175@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 23, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)