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NCT Number: NCT07040670

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

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.

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Key information

Conditions

Mediastinal Lymphadenopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • 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
  • 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
  • There was no contraindication of puncture and cryobiopsy
  • Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.

Exclusion criteria

  • The lesion is a mediastinal cyst or abscess
  • 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

Treatment and study plan

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

Procedure

First, use the EBUS needle to create a hole in the airway wall. Then, insert the CLE into the lymph node via this hole and detect the lymph node. When the specific pathological finding is detected by CLE, record the location. Finally, using the needle to perform EBUS-TBNA in the area under EBUS guidance.

Endobronchial ultrsound-guided Mediastinal cryobiopsy

Procedure

Using the cryoprobe to perform EBUS-TBMC three times per person.

Primary outcomes

  1. Diagnostic yield

    Time frame: On day 7 after procedure to obtain the pathological findings.

    The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingming Deng

CONTACT

[email protected]

+86 18801336854

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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: a Randomised Controlled Trial

Acronym: COLLEBERATIONⅢ

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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