ILDNCT04047667
Cone Beam CT Guided Transbronchial Cryobiopsy
An observational study of ILD, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary assessment of clinical presentations, radiological and histological features. Transbronchial cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident diagnosis cannot be made by clinical and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ILD
- What is being tested?
- cone beam CT guided transbronchial cryobiopsy
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ILD Patients without a diagnosis after integration of clinical profile, laboratory tests and HRCT features
Who may be able to join
- more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%
Who cannot join
- acute exacerbation within one month, bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients with pulmonary hypertension, respiratory failure, liver, kidney disfunction, and cardiac insufficiency, PLT less than 50 x 109/L
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Huaping Dai, MD, 0086-13901293597, daihuaping@sina.com
Guowu Zhou, MD, 0086-13585939427, gwzhou41@163.com
About this study
Official title: The Safety and Diagnostic Efficacy of Cone Beam CT Guided Transbronchial Cryobiopsy for ILD Patients
Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary assessment of clinical presentations, radiological and histological features. Transbronchial cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident diagnosis cannot be made by clinical and radiological assessment. TBCB could lead to higher incidence of risks. The pneumothorax and severe bleeding seemed to be more common in patients with TBCB.
Cone-beam computed tomography (CBCT) could provide 3-dimensinal (3D) CT images which were close to the image qualities of conventional CT. The probe-to-pleura relationship could be accurately established by the 3D CT scan and the cryobiopsy safety profile might be improved under the guidance of CBCT. In this study, we conducted a prospective study to observe the safety and diagnostic efficacy of CBCT guided TBCB for the DPLD patients.
- Conditions
- ILD
- Being tested
- cone beam CT guided transbronchial cryobiopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone beam CT guided transbronchial cryobiopsyProcedure or surgery
CBCT images are acquried and reviewed in axial, coronal and sagittal planes to most accurately assess the cryoprobe position within the lung parenchyma and relative to other thoracic structures. The minimum probe-to-pleura distance will be measured. If the position of cryoprobe is proper, TBCB will be perfomed.
| Study group | Role | What they receive |
|---|---|---|
| CBCT guided TBCB | Patients with ILD who met the following including criteria from September 2018 to July 2019 were suggested to receive TBCB under CBCT guidance: more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%, patients without acute exacerbation within one month, patients without bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients without pulmonary hypertension, respiratory failure, liver or kidney disfunction, or cardiac insufficiency, PLT more than 50 x 109/L. All included patients signed the informed consent. Receives: Procedure: cone beam CT guided transbronchial cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety profile of procedure
pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death.
Measured: 30 days
Secondary outcomes (1)
diagnostic efficacy
diagnostic yield
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ILDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai Huaping, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047667
- Sponsor's protocol ID
- ChinaJapanFH004
- Status last verified
- Aug 2019
- First submitted
- 4 Aug 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bian Y, Deng M, Gao Q, Zhou G, Tong R, Zhao L, Liu M, Sun J, Dai H, Herth FJF, Hou G, Wang C. The Diagnostic Efficiency and Safety of Transbronchial Lung Cryobiopsy Using 1.1-mm Cryoprobe in Diagnosing Interstitial Lung Disease. Lung. 2024 Oct;202(5):615-623. doi: 10.1007/s00408-024-00713-2. Epub 2024 Jun 23.
PubMed 38910197Bian Y, Zhou G, Gao Q, Deng M, Tong R, Xia Y, Lin J, Hou G, Dai H. Assessment of a randomized controlled trial on the safety of pre-placing bronchial balloons in transbronchial lung cryobiopsy for diagnosing interstitial lung disease. Eur J Med Res. 2024 May 3;29(1):268. doi: 10.1186/s40001-024-01871-y.
PubMed 38702744
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Diagnostic Efficacy of Cone Beam CT Guided Transbronchial Cryobiopsy for ILD Patients
- ClinicalTrials.gov ID
- NCT04047667
- Acronym / sponsor ID
- ChinaJapanFH004
- Conditions
- ILD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 Aug 2019 (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.
Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary assessment of clinical presentations, radiological and histological features. Transbronchial cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident diagnosis cannot be made by clinical and radiological assessment. TBCB could lead to higher incidence of risks. The pneumothorax and severe bleeding seemed to be more common in patients with TBCB.
Cone-beam computed tomography (CBCT) could provide 3-dimensinal (3D) CT images which were close to the image qualities of conventional CT. The probe-to-pleura relationship could be accurately established by the 3D CT scan and the cryobiopsy safety profile might be improved under the guidance of CBCT. In this study, we conducted a prospective study to observe the safety and diagnostic efficacy of CBCT guided TBCB for the DPLD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT guided TBCB | – | Procedure: cone beam CT guided transbronchial cryobiopsyPatients with ILD who met the following including criteria from September 2018 to July 2019 were suggested to receive TBCB under CBCT guidance: more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%, patients without acute exacerbation within one month, patients without bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients without pulmonary hypertension, respiratory failure, liver or kidney disfunction, or cardiac insufficiency, PLT more than 50 x 109/L. All included patients signed the informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ILD Patients without a diagnosis after integration of clinical profile, laboratory tests and HRCT features
Key inclusion criteria (1 listed)
- more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%
Key exclusion criteria (1 listed)
- acute exacerbation within one month, bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients with pulmonary hypertension, respiratory failure, liver, kidney disfunction, and cardiac insufficiency, PLT less than 50 x 109/L
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 |
|---|---|---|
| cone beam CT guided transbronchial cryobiopsyCBCT images are acquried and reviewed in axial, coronal and sagittal planes to most accurately assess the cryoprobe position within the lung parenchyma and relative to other thoracic structures. The minimum probe-to-pleura distance will be measured. If the position of cryoprobe is proper, TBCB will be perfomed. | Procedure or surgery | CBCT guided TBCB |
Primary outcome
safety profile of procedure
Time frame: 30 days
pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death.
1 secondary outcome
diagnostic efficacy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 38910197Bian Y, Deng M, Gao Q, Zhou G, Tong R, Zhao L, Liu M, Sun J, Dai H, Herth FJF, Hou G, Wang C. The Diagnostic Efficiency and Safety of Transbronchial Lung Cryobiopsy Using 1.1-mm Cryoprobe in Diagnosing Interstitial Lung Disease. Lung. 2024 Oct;202(5):615-623. doi: 10.1007/s00408-024-00713-2. Epub 2024 Jun 23.
- Derived from this study: PubMed 38702744Bian Y, Zhou G, Gao Q, Deng M, Tong R, Xia Y, Lin J, Hou G, Dai H. Assessment of a randomized controlled trial on the safety of pre-placing bronchial balloons in transbronchial lung cryobiopsy for diagnosing interstitial lung disease. Eur J Med Res. 2024 May 3;29(1):268. doi: 10.1186/s40001-024-01871-y.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ILD, 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 1 inclusion and 1 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 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety profile of procedure (time frame: 30 days). 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 NCT04047667, which also lists 2 linked publications.
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 Aug 2019.