The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases

• Conditions: Diffuse Parenchymal Lung Diseases

• Registration Number: NCT03704233
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Study Start: 2018-11-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07
• Primary Completion: 2020-10-20
• Study Completion: 2021-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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: OBSERVATIONAL
• Study Design: Not specified

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	12 weeks	Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy (in 12 weeks).

Trial Locations

Locations (26)

AnHui Chest Hospital; 🇨🇳 Hefei, Anhui, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Xiamen Second Hospital; 🇨🇳 Xiamen, Fujian, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

the First Affiliated Hospital Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Shenzhen Guangming New District People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

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