Clinical trial NCT03704233: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases
Official title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Parenchymal Lung Diseases
Keywords: Transbrochial cryobiopsy
Diffuse parenchymal lung diseases
Diagnosis
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnotic yield
timeFrame: two weeks
Secondary outcomes:
measure: Complication rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: AnHui Chest Hospital
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Second Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: the First Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Guangming New District People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Affiliated Zhongshan Hospital of Guangdong Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Central Hospital Of WuHan
state: Hubei
city: Wuhan
country: China
facility: Department of Respiratory and Critical Care Medicine，Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: People's Hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: XiangYa Hospital Central South University
state: Hunan
city: Dalian
country: China
facility: Dalian Muncipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Shengyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Xi'an
country: China
facility: Xi'an chest hospital
state: Shanxi
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital of Sichuan University
state: Sichuan
city: MianYang
country: China
facility: MianYang Central Hospital
state: Sichuan
city: Taizhong
country: China
facility: China Medical University Hospital
state: Taiwan
city: Jiaxing
country: China
facility: The first Hospital of Jiaxing
state: Zhejiang
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li
role: STUDY_CHAIR
References:
citation: Chen X, Li J, Luo F, Tao F, Zhang X, Wu Y, Xu P, Ke M, Long F, Liu L, Lv L, Liao H, Gu Y, Liu Z, Tan X, Guo S, Hu Y, Yang H, Zhou Y, Zhou H, Ye Y, Chen D, Li S. The application of transbronchial cryobiopsy in interstitial lung disease: a prospective, multicenter, real-world study. Ann Transl Med. 2021 Nov;9(22):1645. doi: 10.21037/atm-21-3461.