Combined EBUS needle aspiration and mediastinal cryobiopsy to diagnose lung cancer spread

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

This trial tries adding EBUS-guided mediastinal cryobiopsy to standard EBUS-TBNA to see if it improves diagnosis for adults with suspected mediastinal metastases of lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07488507 on ClinicalTrials.gov

What this trial studies

Adults with mediastinal lesions will be randomly assigned to receive standard endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) alone or EBUS-TBNA followed by EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB). Biopsy specimens from both groups will be reviewed by pathologists to determine diagnostic yield and to identify pathological subtype. All participants will be followed for confirmation of diagnosis and for procedure-related complications. The trial compares diagnostic accuracy and the incidence of adverse events between the combined approach and the standard needle aspiration alone.

Who should consider this trial

Good fit: Adults aged 18 or older with at least one mediastinal lesion ≥10 mm on thin-slice chest CT who need a mediastinal biopsy for suspected, confirmed (for staging), or recurrent lung cancer and who can provide informed consent are eligible.

Not a fit: Patients with contraindications to bronchoscopy or anesthesia—such as severe cardiopulmonary disease, coagulation disorders, massive hemoptysis—or where EBUS exploration of the lesion fails are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combined approach could provide more accurate diagnoses and staging from a single procedure, reducing the need for repeat biopsies and enabling more timely treatment decisions.

How similar studies have performed: Standard EBUS-TBNA is well established, while adding transbronchial mediastinal cryobiopsy is relatively novel with some small studies suggesting improved tissue yield but not yet widely validated.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing Municipality

• Third Military Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hanbing Wang

Conditions Mediastinal Metastases of Lung Cancer