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

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Unknown status

CT.gov ID

NCT03927235

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transbronchial Cryobiopsy Freezing Time Diagnostic Yield Safety	Procedure: Transbronchial Cryobiopsy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial

Actual Study Start Date :

May 16, 2019

Anticipated Primary Completion Date :

May 15, 2020

Anticipated Study Completion Date :

May 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: the freezing time of 3s Transbronchial cryobiopsy in the freezing time of 3s	Procedure: Transbronchial Cryobiopsy Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
Experimental: the freezing time of 4s Transbronchial cryobiopsy in the freezing time of 4s	Procedure: Transbronchial Cryobiopsy Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
Experimental: the freezing time of 5s Transbronchial cryobiopsy in the freezing time of 5s	Procedure: Transbronchial Cryobiopsy Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
Experimental: the freezing time of 6s Transbronchial cryobiopsy in the freezing time of 6s	Procedure: Transbronchial Cryobiopsy Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Outcome Measures

Primary Outcome Measures

Diagnotic yield [two weeks]
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy

Secondary Outcome Measures

Complication rate [one week]
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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