Not yet recruiting NCT07040670

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

No phase Interventional Mediastinal Lymphadenopathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration, Endobronchial ultrsound-guided Mediastinal cryobiopsy.
Who it may be relevant to: Registry conditions: Mediastinal Lymphadenopathies. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

Interventions

Procedure Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration
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.
Procedure Endobronchial ultrsound-guided Mediastinal cryobiopsy
Using the cryoprobe to perform EBUS-TBMC three times per person.

Primary outcome measures

Diagnostic yield [Time frame: On day 7 after procedure to obtain the pathological findings.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

Zheng Z, Xu L, Wu C, Liao J, Deng M, Tong R, Hou G. Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided needle aspiration in diagnosing mediastinal and/or hilar lymphadenopathy (COLLABORATION-III): protocol for a randomised controlled trial. BMJ Open Respir Res. 2026 Jun 24;13(1):e004263. doi: 10.1136/bmjresp-2026-004263. PMID 42342291

Identifiers

NCT: NCT07040670 · 2025-COLLEBERATION-Ⅲ

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗