The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule

ShiYue Li

Status: Unknown

Conditions: Complication Rate; Diagnosis

Treatments: Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)

Study type: Interventional

Funder types: Other

Identifiers

NCT04661956

20200914

Details and patient eligibility

About

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.

Full description

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.
2. The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.
3. The Pulmonary Periphral Nodule can be detected by radial-EBUS
4. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
5. Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.

Exclusion criteria

1. The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
2. The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
3. The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Transbronchial cryobiopsy

Experimental group

Description:

Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule

Treatment:

Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)

Transbronchial lung biopsy

Other group

Description:

Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule

Treatment:

Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)