The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases
1 other identifier
observational
350
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedMarch 7, 2019
March 1, 2019
2 years
September 25, 2018
March 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnotic yield
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
two weeks
Secondary Outcomes (1)
Complication rate
12 weeks
Study Arms (1)
Cryobiopsy
Transbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
Interventions
Eligibility Criteria
Inpatients
You may qualify if:
- 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.
You may not qualify if:
- The radiological data indicates non-DPLD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
AnHui Chest Hospital
Hefei, Anhui, 230003, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Xiamen Second Hospital
Xiamen, Fujian, 361021, China
Guangdong General Hospital
Guangzhou, Guangdong, 510000, China
the First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Shenzhen Guangming New District People's Hospital
Shenzhen, Guangdong, 518106, China
Affiliated Zhongshan Hospital of Guangdong Medical University
Zhongshan, Guangdong, 528415, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The Central Hospital Of WuHan
Wuhan, Hubei, 430014, China
Department of Respiratory and Critical Care Medicine，Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
People's Hospital of Hunan Province
Changsha, Hunan, 410005, China
XiangYa Hospital Central South University
Changsha, Hunan, 410008, China
Dalian Muncipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033, China
The First Hospital of China Medical University
Shengyang, Liaoning, 110001, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Renji Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201112, China
Xi'an chest hospital
Xi’an, Shanxi, 710010, China
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
MianYang Central Hospital
Mianyang, Sichuan, 621000, China
China Medical University Hospital
Taizhong, Taiwan, 40447, China
The first Hospital of Jiaxing
Jiaxing, Zhejiang, 314000, China
Related Publications (1)
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.
PMID: 34988154DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shiyue Li
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Respiratory Medicine
Study Record Dates
First Submitted
September 25, 2018
First Posted
October 12, 2018
Study Start
November 1, 2018
Primary Completion
October 20, 2020
Study Completion
October 20, 2021
Last Updated
March 7, 2019
Record last verified: 2019-03