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

Not Applicable

• Conditions: Diagnostic Yield; Transbronchial Cryobiopsy; Freezing Time; Safety
• Interventions: Procedure: Transbronchial Cryobiopsy

• Registration Number: NCT03927235
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

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 Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Status Verified: 2019-05
• Study Start: 2019-05-16
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the freezing time of 5s	Transbronchial Cryobiopsy	Transbronchial cryobiopsy in the freezing time of 5s
the freezing time of 3s	Transbronchial Cryobiopsy	Transbronchial cryobiopsy in the freezing time of 3s
the freezing time of 6s	Transbronchial Cryobiopsy	Transbronchial cryobiopsy in the freezing time of 6s
the freezing time of 4s	Transbronchial Cryobiopsy	Transbronchial cryobiopsy in the freezing time of 4s

Primary Outcome Measures

Name	Time	Method
Diagnotic yield	two weeks	Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China