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

Diffuse Parenchymal Lung Diseases Clinical Trial

Official title:

The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03704233
• Other study ID #: 2018-03-13
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: October 20, 2021

Study information

• Verified date: March 2019
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Shiyue Li
• Phone: 8620-83062896
• Email: lishiyue[@]188.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Parenchymal Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Transbronchial cryobiopsy
Transbronchial cryobiopsy procedure

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	People's Hospital of Hunan Province	Changsha	Hunan
China	XiangYa Hospital Central South University	Changsha	Hunan
China	West China School of Medicine/West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian Muncipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	Guangdong General Hospital	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	the First Affiliated Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	AnHui Chest Hospital	Hefei	Anhui
China	The first Hospital of Jiaxing	Jiaxing	Zhejiang
China	MianYang Central Hospital	MianYang	Sichuan
China	Renji Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shengyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen Guangming New District People's Hospital	Shenzhen	Guangdong
China	China Medical University Hospital	Taizhong	Taiwan
China	Department of Respiratory and Critical Care Medicine,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei
China	The Central Hospital Of WuHan	Wuhan	Hubei
China	Xi'an chest hospital	Xi'an	Shanxi
China	Xiamen Second Hospital	Xiamen	Fujian
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Affiliated Zhongshan Hospital of Guangdong Medical University	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnotic yield	Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy	two weeks
Secondary	Complication rate	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).	12 weeks