Diffuse Parenchymal Lung DiseasesNCT03704233
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases
An observational study of Diffuse Parenchymal Lung Diseases, run by Guangzhou Institute of Respiratory Disease at 26 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse Parenchymal Lung Diseases
- What is being tested?
- Transbronchial cryobiopsy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 26 sitesChina
- Study dates
- 1 Nov 2018to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients
Who may be able to join
- 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.
Who cannot join
- The radiological data indicates non-DPLD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites, 26 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Xiaoping Wang, PhD, 18600569233, wang_xpx@163.com
- Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410005
Zhiguang Liu, MD, 073183928074, liuzhiguang0404@126.com
Wei Liu, PhD, 073183920874
- Not yet recruiting
XiangYa Hospital Central South University
Changsha, Hunan, 410008
Hua Ping Yang, PhD, 13973129956, lyhuaping@aliyun.com
- Recruiting
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Feng Ming Luo, PhD, 18980601355, luofengming@hotmail.com
Dan Liu, PhD, 028-85422580, 1103432159@qq.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Shuliang Guo, PhD, 023-89012097, GUOSL999@sina.com
Yishi Li, MD, 023-89012692, KEVIN2003LEE@163.com
- Not yet recruiting
Dalian Muncipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033
Chun Fang Liu, MD, 13804241131, zxyylcf611@126.com
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510000
Jing Li, PhD, 13825009393, 472522080@qq.com
Wenfang Chen, BD, 17701966969, 823238179@qq.com
- Not yet recruiting
the First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510080
Huai Liao, MD, 020-87755766-8171, liaohuai1208@hotmail.com
Xinyan Huang, PhD, 020-87755766-8171
- Recruiting
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Shiyue Li, MD, 8620-83062896, lishiyue@188.com
Xiaobo Chen, MD, 8620-83062885, xiaobo-win@163.com
- Not yet recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Lai Yu Liu, PhD, 13632102245, liulaiyu@126.com
Wen Qi Huang, MD, 13712920984, 494435398@163.com
- Not yet recruiting
AnHui Chest Hospital
Hefei, Anhui, 230003
Liping Lv, BD, 13956954712, Lvliping1759@sina.com
Fei Tang, MD, 13505696936, tangfei1205@163.com
- Recruiting
The first Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Feng Tao, BD, 0573-82082937, piaopiaogou@163.com
Na Li, MD, 0573-82082937
- Recruiting
MianYang Central Hospital
Mianyang, Sichuan, 621000
You Lv Wu, BD, 13778138872, 18981117387@163.com
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, PhD, 021-22201512, jysun1976@163.com
Zheng Xiaoxuan, MD, 021-22201512, milozheng59@163.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Hao Wang, MD, 13817624060, drsymons@outlook.com
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201112
Tang Xiao Ming, PhD, 13774269509, tanxiaomingfsh@163.com
Yu Zheng, MD, 13817846612, Drzhengyu@yahoo.com
- Not yet recruiting
The First Hospital of China Medical University
Shengyang, Liaoning, 110001
Gang Hou, PhD, 13840065481, hou_gang@163.com
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Ping Xu, PhD, 0755-83923333, 799721206@qq.com
WD Song, PhD, 0755-83923333, SongWD123@hotmail.com
- Recruiting
Shenzhen Guangming New District People's Hospital
Shenzhen, Guangdong, 518106
Fa Long, MD, 13651472098, longfa_923@163.com
Peng Fu, BD, 15989380761, 843999103@qq.com
- Not yet recruiting
China Medical University Hospital
Taizhong, Taiwan, 40447
Chih-yen Tu, PhD, 886-4-22052121-3483, chesttu@gmail.com
Chia-Hung Chen, PhD, 886-4-22052121-3483, hsnu758@gmail.com
- Not yet recruiting
The Central Hospital Of WuHan
Wuhan, Hubei, 430014
Yi Hu, MD, 13995618974, huyi_pub@163.com
Wen Yin, MD, 15827232797, evan_wen@126.com
- Not yet recruiting
Department of Respiratory and Critical Care Medicine，Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Jian Ping Zhao, PhD, 02783663615, zhaojp88@126.com
Peng Zuo, MD, 02783663617, zuopeng1123@163.com
- Recruiting
Xi'an chest hospital
Xi’an, Shanxi, 710010
Yong Zhou, MD, 02962500170, 18729378033@163.com
Chao Ruan, BD, 02962500170, 1225980995@qq.com
- Not yet recruiting
Xiamen Second Hospital
Xiamen, Fujian, 361021
Ming Yao Ke, BD, 13860166866, 13860166866@126.com
Rui Huang, BD, 15392037355, huangrui_0805@163.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xiaoju Zhang, PhD, 0371-65580653, 15837101166@163.com
Quncheng Zhang, MD, 0371-65580330, zcc_0813@126.com
- Not yet recruiting
Affiliated Zhongshan Hospital of Guangdong Medical University
Zhongshan, Guangdong, 528415
Hong Mei Zhou, BD, 13822715685, zhouhongmei2011e@163.com
About this study
Official title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study
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.
- Conditions
- Diffuse Parenchymal Lung Diseases
- Being tested
- Transbronchial cryobiopsy
- Keywords
- Transbrochial cryobiopsy, Diffuse parenchymal lung diseases, Diagnosis
- Medical subject headings
- Lung Diseases, Interstitial, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial cryobiopsyProcedure or surgery
Transbronchial cryobiopsy procedure
| Study group | Role | What they receive |
|---|---|---|
| Cryobiopsy | Transbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. Receives: Procedure: Transbronchial cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnotic yield
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
Measured: two weeks
Secondary outcomes (1)
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Nov 2018
- Primary completion20 Oct 2020 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Parenchymal Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, Study chair, Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704233
- Sponsor's protocol ID
- 2018-03-13
- Status last verified
- Mar 2019
- First submitted
- 25 Sep 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34988154
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study
- ClinicalTrials.gov ID
- NCT03704233
- Acronym / sponsor ID
- 2018-03-13
- Conditions
- Diffuse Parenchymal Lung Diseases
- Keywords
- Transbrochial cryobiopsy, Diffuse parenchymal lung diseases, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryobiopsy | – | Procedure: Transbronchial cryobiopsyTransbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- The radiological data indicates non-DPLD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbronchial cryobiopsyTransbronchial cryobiopsy procedure | Procedure or surgery | Cryobiopsy |
Primary outcome
Diagnotic yield
Time frame: two weeks
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
1 secondary outcome
Complication rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 34988154Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyue Li study chair
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Parenchymal Lung Diseases, run by Guangzhou Institute of Respiratory Disease at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li (8620-83062896, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnotic yield (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.