Transbronchial Lung CryobiopsyNCT06245954
The Role of Standardized Training in the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy
A study testing simulated training and traditional bedside teaching in people with Transbronchial Lung Cryobiopsy, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transbronchial Lung Cryobiopsy
- What is being tested?
- simulated training and traditional bedside teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- suspected ILD.
- ≤3 months since HRCT
- Forced vital capacity (FVC) ≥50% of predicted value
- Diffused lung carbon monoxide (DLCO) ≥35% predicted value
- Echocardiography ≤ 12 months
Show all 9Show fewer
- Estimated pulmonary artery systolic pressure ≤40 mmHg
- Body mass index (BMI) ≤35 kg/m2
- Patient consent for experimentation
Who cannot join
- Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5
- Patients refused to participate in the experiment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, 18801336854, isdeng1017@163.com
About this study
Official title: Learning Curve for the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy and the Role of Standardized Training in It
The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.
- Conditions
- Transbronchial Lung Cryobiopsy
- Being tested
- simulated training, traditional bedside teaching
- Keywords
- transbronchial lung cryobiopsy, standardized training, learning curve, bronchoscopist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulated trainingOther
Simulation training of bronchoscopists by means of simulators and extracorporeal lungs
traditional bedside teachingOther
TBLC training for bronchoscopists through traditional lectures, hands-on demonstrations
| Study group | Role | What they receive |
|---|---|---|
| Standardized training group | Experimental | The bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs Receives: Other: simulated training |
| Traditional teaching model group | Other | The bronchoscopists in this group will accept traditional lectures, hands-on demonstrations and so on to learn TBLC Receives: Other: traditional bedside teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain pathologic quality assessment of specimens
The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.
Measured: 1 month
histopathological pattern diagnosis rate
Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.
Measured: 1 month
diagnostic rate of multidisciplinary discussions
Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts
Measured: 1 month
Secondary outcomes (1)
Occurrence of short-term adverse events
bleeding and pneumothorax occurred with 24 hours after TBLC, acute exacerbation of ILD and death occurred with 7 days after TBLC
Measured: 24 hours or 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transbronchial Lung CryobiopsyStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245954
- Sponsor's protocol ID
- ZRJY2021-BJ08-03-02
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve for the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy and the Role of Standardized Training in It
- ClinicalTrials.gov ID
- NCT06245954
- Acronym / sponsor ID
- ZRJY2021-BJ08-03-02
- Conditions
- Transbronchial Lung Cryobiopsy
- Keywords
- transbronchial lung cryobiopsy, standardized training, learning curve, bronchoscopist
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2024 (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 aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized training group | Experimental | Other: simulated trainingThe bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs |
| Traditional teaching model group | Other | Other: traditional bedside teachingThe bronchoscopists in this group will accept traditional lectures, hands-on demonstrations and so on to learn TBLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- suspected ILD.
- ≤3 months since HRCT
- Forced vital capacity (FVC) ≥50% of predicted value
- Diffused lung carbon monoxide (DLCO) ≥35% predicted value
Key exclusion criteria (2 listed)
- Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5
- Patients refused to participate in the experiment
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 |
|---|---|---|
| simulated trainingSimulation training of bronchoscopists by means of simulators and extracorporeal lungs | Other | Standardized training group |
| traditional bedside teachingTBLC training for bronchoscopists through traditional lectures, hands-on demonstrations | Other | Traditional teaching model group |
Primary outcome
Obtain pathologic quality assessment of specimens
Time frame: 1 month
The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.
histopathological pattern diagnosis rate
Time frame: 1 month
Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.
diagnostic rate of multidisciplinary discussions
Time frame: 1 month
Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts
1 secondary outcome
Occurrence of short-term adverse events
Time frame: 24 hours or 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulated training and traditional bedside teaching in people with Transbronchial Lung Cryobiopsy, run by China-Japan Friendship Hospital at 1 site 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 9 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain pathologic quality assessment of specimens (time frame: 1 month). The study lists 3 primary outcomes in all. 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 10 Feb 2025.