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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Third Military Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Hanbing Wang
• Email: 18885230175@163.com
• Phone: +86 18885230175

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.