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

N/ANot Yet RecruitingNCT07352176

Guangzhou Medical University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Pulmonary Lesion Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of adverse events

The Incidence of adverse events = (the number of adverse event / the number of procedures) \* 100%

Time frame: 7 days after procedure

Secondary Outcomes

Diagnostic yield

The diagnostic yield = (the number of successful diagnoses / the number of completed biopsies) \* 100%

Time frame: Immediately after the procedure

Hole-in-lesion rate

The rate of "hole-in-lesion" = (The number of cases with "hole-in-lesion" / The total number of cases that completed biopsy) \* 100% The definition of "Hole-in-lesion": After cryobiopsy, a CBCT scan is performed, and the CBCT image shows the presence of a cavity within the lesion.

Time frame: During the procedure