Lung Transplant RejectionNCT05792384
Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation
A study testing transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe and transbronchial lung biopsy with biopsy forceps in people with Lung Transplant Rejection, run by China-Japan Friendship Hospital.
Trial summary
The goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (TBCB) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of TBCB… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe and transbronchial lung biopsy with biopsy forceps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2023to 31 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age among 18-65 years old
- After unilateral or bilateral lung transplantation, patient with unexplained pulmonary function decline, acute/chronic clinical lung injury or new pulmonary infiltrates
- or patients requiring monitoring of rejection after lung transplantation
- The patient should undertake routine preoperative examinations for lung cryobiopsy, including routine blood test, coagulation function, electrocardiogram, and chest CT, and the patients have no contraindications to cryobiopsy
Who cannot join
- patients intolerable to undertake lung biopsy due to severe cardiopulmonary insufficiency or being weak
- The patient is allergic to lidocaine and midazolam
- The patient has recent active massive hemoptysis, or the proposed biopsy site has a high risk of bleeding, such as bronchial artery penetration or suspected renal cancer lung metastasis
- Unstable angina, congestive heart failure, severe bronchial asthma or multiple bullae
- Severe hypertension and arrhythmia, hemodynamic instability and severe respiratory failure (PaO2<60mmHg after oxygen therapy or mechanical ventilation)
- The patient has coagulation disorder and unable to stop taking anticoagulants, antiplatelet drugs, aspirin or non-steroidal anti-inflammatory drugs before lung biopsy
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- Suspected aortic aneurysm
- The patient does not agree to participate in this study
- Participating in other studies within three months and not withdrawing or ending
- The researchers think that the patient are not suitable for inclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on Comprehensive Management of End-stage Severe Chronic Respiratory Diseases - Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation
The goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (TBCB) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of TBCB for monitoring after lung transplantation, It is expected to provide a better auxiliary examination method for lung transplantation.
The main questions it aims to answer are: (1) Histopathological evaluability of specimens; (2) Safety of TBCB; (3) Size and quality of specimen, and number of attempts to obtain five samples.
Participants will undergo TBCB with 1.1 mm flexible cryoprobe or traditional transbronchial lung biopsy with biopsy forceps.
- Conditions
- Lung Transplant Rejection
- Being tested
- transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe, transbronchial lung biopsy with biopsy forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobeProcedure or surgery
Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe
transbronchial lung biopsy with biopsy forcepsProcedure or surgery
Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps
| Study group | Role | What they receive |
|---|---|---|
| transbronchial cryobiopsy | Experimental | transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe Receives: Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe |
| transbronchial lung biopsy | Active comparator | transbronchial lung biopsy with biopsy forceps Receives: Procedure: transbronchial lung biopsy with biopsy forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection
Diagnostic yield of transbronchial cryobiopsy (TBCB) for diagnosing the lung transplantation rejection, compare with that of traditional transbronchial lung biopsy. The reference standard is the result of Multi-Disciplinary Treatment (MDT).
Measured: 7 days after lung biopsy
Secondary outcomes (6)
Incidence of complications
Incidence of complications
Measured: one day, 3 days and 7 days after lung biopsy
Sample size
The area size of the biopsy sample will be measured using the software Image J (version 1.48; Maryland, MD, USA) , and measured in square millimetres.
Measured: during surgery
the number of alveoli in the biopsy sample
The number of alveoli in the biopsy sample is recorded, according to the histological analysis of the biopsy paraffin section.
Measured: 7 days after lung biopsy
the number of blood vessels in the biopsy sample
The number of blood vessels in the biopsy sample is recorded, according to the histological analysis of the biopsy paraffin section.
Measured: 7 days after lung biopsy
the percentage of the area of lung parenchyma without artifacts in the biopsy sample
The percentage of the area of lung parenchyma without artifacts in the biopsy sample is measured (by the software Image J) and recorded, according to the histological analysis of the biopsy paraffin section.
Measured: 7 days after lung biopsy
number of attempts to get five samples
number of attempts to get five samples
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start6 Apr 2023 (estimated)
- Primary completion24 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting Yang, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792384
- Sponsor's protocol ID
- 2021-I2M-1-049-03-TBCB
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Comprehensive Management of End-stage Severe Chronic Respiratory Diseases - Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation
- ClinicalTrials.gov ID
- NCT05792384
- Acronym / sponsor ID
- 2021-I2M-1-049-03-TBCB
- Conditions
- Lung Transplant Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 6 Apr 2023 (estimated)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Mar 2023 (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 goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (TBCB) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of TBCB for monitoring after lung transplantation, It is expected to provide a better auxiliary examination method for lung transplantation.
The main questions it aims to answer are: (1) Histopathological evaluability of specimens; (2) Safety of TBCB; (3) Size and quality of specimen, and number of attempts to obtain five samples.
Participants will undergo TBCB with 1.1 mm flexible cryoprobe or traditional transbronchial lung biopsy with biopsy forceps.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transbronchial cryobiopsy | Experimental | Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobetransbronchial cryobiopsy with a 1.1 mm flexible cryoprobe |
| transbronchial lung biopsy | Active comparator | Procedure: transbronchial lung biopsy with biopsy forcepstransbronchial lung biopsy with biopsy forceps |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age among 18-65 years old
- After unilateral or bilateral lung transplantation, patient with unexplained pulmonary function decline, acute/chronic clinical lung injury or new pulmonary infiltrates
- or patients requiring monitoring of rejection after lung transplantation
- The patient should undertake routine preoperative examinations for lung cryobiopsy, including routine blood test, coagulation function, electrocardiogram, and chest CT, and the patients have no contraindications to cryobiopsy
Key exclusion criteria (10 listed)
- patients intolerable to undertake lung biopsy due to severe cardiopulmonary insufficiency or being weak
- The patient is allergic to lidocaine and midazolam
- The patient has recent active massive hemoptysis, or the proposed biopsy site has a high risk of bleeding, such as bronchial artery penetration or suspected renal cancer lung metastasis
- Unstable angina, congestive heart failure, severe bronchial asthma or multiple bullae
- Severe hypertension and arrhythmia, hemodynamic instability and severe respiratory failure (PaO2<60mmHg after oxygen therapy or mechanical ventilation)
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 lung cryobiopsy with a 1.1 mm flexible cryoprobeObtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe | Procedure or surgery | transbronchial cryobiopsy |
| transbronchial lung biopsy with biopsy forcepsObtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps | Procedure or surgery | transbronchial lung biopsy |
Primary outcome
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection
Time frame: 7 days after lung biopsy
Diagnostic yield of transbronchial cryobiopsy (TBCB) for diagnosing the lung transplantation rejection, compare with that of traditional transbronchial lung biopsy. The reference standard is the result of Multi-Disciplinary Treatment (MDT).
6 secondary outcomes
Incidence of complications
Time frame: one day, 3 days and 7 days after lung biopsy
Sample size
Time frame: during surgery
the number of alveoli in the biopsy sample
Time frame: 7 days after lung biopsy
the number of blood vessels in the biopsy sample
Time frame: 7 days after lung biopsy
the percentage of the area of lung parenchyma without artifacts in the biopsy sample
Time frame: 7 days after lung biopsy
number of attempts to get five samples
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
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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.
Ting Yang, MD principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A study testing transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe and transbronchial lung biopsy with biopsy forceps in people with Lung Transplant Rejection, run by China-Japan Friendship Hospital.
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 4 inclusion and 10 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Run Tong, MD (010-84205729, tong-run@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection (time frame: 7 days after lung biopsy). 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 31 Mar 2023.