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

Guangzhou Medical University

Status: Not yet enrolling

Conditions: Pulmonary Lesion; Lung Cancer

Treatments: Other: Conventional cryobiopsy; Other: Confocal laser endomicroscopy combined cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07352176

CLE-Cryo

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Diffuse- Conventional Group

Active Comparator group

Description:

The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions.

Treatment:

Other: Conventional cryobiopsy

Diffuse- Combined Group

Experimental group

Description:

The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions

Treatment:

Other: Confocal laser endomicroscopy combined cryobiopsy

Localized - Convention Group

Active Comparator group

Description:

The Localized-Conventional Group used conventional cryobiopsy for lung lesions.

Treatment:

Other: Conventional cryobiopsy

Localized - Combined Group

Experimental group

Description:

The Localized-Combined Group used CLE combined with cryobiopsy for lung lesions

Treatment:

Other: Confocal laser endomicroscopy combined cryobiopsy