The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Transbronchial Cryobiopsy; Freezing Time; Diagnostic Yield; Safety

Treatments: Procedure: Transbronchial Cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03927235

2018-3-30

Details and patient eligibility

About

Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.

Full description

Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.
2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.

Exclusion criteria

1. The radiological data indicates non-DPLD
2. The clinical examinations mentioned above are not completed.
3. 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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80 participants in 4 patient groups

the freezing time of 3s

Sham Comparator group

Description:

Transbronchial cryobiopsy in the freezing time of 3s

Treatment:

Procedure: Transbronchial Cryobiopsy

the freezing time of 4s

Experimental group

Description:

Transbronchial cryobiopsy in the freezing time of 4s

Treatment:

Procedure: Transbronchial Cryobiopsy

the freezing time of 5s

Experimental group

Description:

Transbronchial cryobiopsy in the freezing time of 5s

Treatment:

Procedure: Transbronchial Cryobiopsy

the freezing time of 6s

Experimental group

Description:

Transbronchial cryobiopsy in the freezing time of 6s

Treatment:

Procedure: Transbronchial Cryobiopsy