Diagnostic Yield and Safety of Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (COLLEBERATIONⅢ)

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Mediastinal Lymphadenopathies

Treatments: Procedure: Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration; Procedure: Endobronchial ultrsound-guided Mediastinal cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07040670

2025-COLLEBERATION-Ⅲ

Details and patient eligibility

About

Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy in patients with mediastinal and/or hilar lymphadenopathy.

Enrollment: 469 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years old
2. Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) without a known or suspected primary lung cancer, required diagnostic bronchoscopy
3. The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc
4. There was no contraindication of puncture and cryobiopsy
5. Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.

Exclusion criteria

1. The lesion is a mediastinal cyst or abscess
2. The patient is allergic to lidocaine and midazolam （3) The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer (4) Unstable angina pectoris, congestive heart failure, severe bronchial asthma

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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469 participants in 2 patient groups, including a placebo group

CLE-assisted EBUS-TBNA

Experimental group

Description:

Patients in this arm receive CLE-assisted EBUS-TBNA

Treatment:

Procedure: Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration

EBUS-TBMC

Placebo Comparator group

Description:

Patients in this arm receive EBUS-TBMC

Treatment:

Procedure: Endobronchial ultrsound-guided Mediastinal cryobiopsy