DiagnosisNCT04661956
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule
A study testing Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) in people with Diagnosis and Complication Rate, run by ShiYue Li at 24 sites in China.
Trial summary
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diagnosis, Complication Rate
- What is being tested?
- Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 24 sitesChina
- Study dates
- 15 Dec 2020to 15 Jun 2022
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.
- The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.
- The Pulmonary Periphral Nodule can be detected by radial-EBUS
- Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.
Who cannot join
- The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
- The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
- The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites, 24 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Hou Gang, 13840065481, hou_gang@163.com
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Li Wei, 13965282263, bbmcliwei@126.com
Gong Beilei, 13155220218, huihuang889@sina.com
- Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410005
Liu Zhiguang, master, 0731-83928074, liuzhiguang0404@126.com
- Not yet recruiting
XiangYa Hospital Central South University
Changsha, Hunan, 410008
Yang Huaping, doctor, 13973129956, lyhuaping@aliyun.com
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510000
Li Jing, doctor, 13825009393, 472522080@qq.com
Luo Shaohua
- Recruiting
The First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510080
Liao Huai, master, 020-87755766-8171, liaohuai1208@hotmail.com
- Not yet recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Liu Laiyu, doctor, 13632102245, liulaiyu@126.com
- Not yet recruiting
AnHui Chest Hospital
Hefei, Anhui, 230003
Lv Liping, bachelor, 13956954712, lvliping1759@sina.com
- Not yet recruiting
Zhejiang Provincial People' s Hospital
Huangzhou, Zhejiang, 310014
Mu Deguang, mudeguang@126.com
Shao Fangchun, shaofc@139.com
- Not yet recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Tao Feng, bachelor, 0573-82082937, piaopiaogou@163.com
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Wan Yixin, 13919267218, 1019374153@qq.com
Wu Fanqi, 13919236833, 173616886@qq.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730099
Yue Hongmei, 13893265368, Yuehongme@csco.org.cn
Pu Jiayuan, 13883139643, pujiayuan@hotmail.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209
Xu Fei, 13870877117, 532712825@qq.com
Zou Meihong, 13870969460, zoumh197011@163.com
- Not yet recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Ding Ming, 18951610130, maolading_527@sina.com
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Sun Jiayuan, master, 18017321598, jysun1976@163.com
Chen Junxiang
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Gu Ye, master, 13817624060, drsymons@outlook.com
Yang Li
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Xu Ping, doctor, 0755-83923333, 799721206@qq.com
Song WD, doctor, 0755-83923333, SongWD123@hotmail.com
- Not yet recruiting
Shenzhen Guangming New District People's Hospital
Shenzhen, Guangdong, 518106
Long Fa, master, 13651472098, longfa_923@163.com
- Not yet recruiting
The Central Hospital Of WuHan
Wuhan, Hubei, 430014
Hu Yi, master, 13995618974, huyi_pub@163.com
- Not yet recruiting
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan, Hubei, 430015
Zhang Jixian, 13377897297, jxzhang1607@163.com
- Not yet recruiting
Xi'an chest hospital
Xi’an, Shanxi, 710010
Zhou Yong, master, 029-62500170, 18729378033@163.com
- Not yet recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Li Manxiang, 18192250387, manxiangli@hotmail.com
Dang Xiaomei, 13319285867, dxming112@163.com
- Recruiting
Xiamen Second Hospital
Xiamen, Fujian, 361021
Ke Mingyao, bachelor, 13860166866, 13860166866@126.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zhang Xiaoju, doctor, 0371-65580653, 15837101166@163.com
Zhang Quncheng, master, 0371-65580330, zcc_0813@126.com
About this study
Official title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.
Read the detailed description
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.
- Conditions
- Diagnosis, Complication Rate
- Being tested
- Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)
- Keywords
- Transbronchial Cryobiopsy, Diagnostic Yield, Safety, Pulmonary Periphral Nodule
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)Procedure or surgery
Transbronchial lung biopsy by cryoprobe or by forcep
| Study group | Role | What they receive |
|---|---|---|
| Transbronchial cryobiopsy | Experimental | Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule Receives: Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) |
| Transbronchial lung biopsy | Other | Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule Receives: Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) |
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
Measured: six months
Secondary outcomes (1)
Complication rate
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start15 Dec 2020
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective multicenter random control trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiYue Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, master, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661956
- Sponsor's protocol ID
- 20200914
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial
- ClinicalTrials.gov ID
- NCT04661956
- Acronym / sponsor ID
- 20200914
- Conditions
- Diagnosis, Complication Rate
- Keywords
- Transbronchial Cryobiopsy, Diagnostic Yield, Safety, Pulmonary Periphral Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ShiYue LiUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 10 Dec 2020 (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.
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.
Detailed description
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospective multicenter random control trial
| Arm | Type | Receives |
|---|---|---|
| Transbronchial cryobiopsy | Experimental | Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule |
| Transbronchial lung biopsy | Other | Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.
- The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.
- The Pulmonary Periphral Nodule can be detected by radial-EBUS
- Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.
Key exclusion criteria (3 listed)
- The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
- The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
- 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 cryobiopsy/Transbronchial lung biopsy (forcep)Transbronchial lung biopsy by cryoprobe or by forcep | Procedure or surgery | Transbronchial cryobiopsy, Transbronchial lung biopsy |
Primary outcome
Diagnotic yield
Time frame: six months
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy
1 secondary outcome
Complication rate
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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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, master study chair
The First Affiliated Hospital of Guangzhou Medical University
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) in people with Diagnosis and Complication Rate, run by ShiYue Li at 24 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 5 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 Xiaobo Chen, Doctor (+8613751721744, xiaobo-win@163.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: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2021.