Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions

Starting soon · Not applicable

Conditions studied: Pulmonary Lesion, Lung Cancer

In brief

Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.

Key facts

Study ID

NCT07352176

Run by

Guangzhou Medical University

People needed

40

Starts

2026-02-01

Expected to finish

2026-12-31

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients over 18 years old with lung lesions indicated by chest CT;
• Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;
• Able to understand and voluntarily sign the written informed consent form. -

You may not qualify if…

• Patients with contraindications to anesthesia or bronchoscopy;
• Patients with uncorrectable coagulation disorders;
• Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
• Patients with severe liver or kidney dysfunction, mental illness, etc.;
• Pregnant or lactating patients;
• Patients without a clear histological or clinical diagnosis;
• Subjects deemed unsuitable for participation in this study by the investigator.

Where it is running

• The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163 — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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