Mediastinal LymphadenopathyNCT04572984
Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions
A study testing EBUS-TBMCB in people with Mediastinal Lymphadenopathy, run by Third Military Medical University at 2 sites in 2 countries.
Trial summary
The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Mediastinal Lymphadenopathy
- What is being tested?
- EBUS-TBMCB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 30 Apr 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >=15 years;
- More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT;
- Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
- Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
- Informed consent form achievement.
Who cannot join
- Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
- Failure to detect the mediastinal lesions in ultrasonic landscape;
- Cysts or abscess;
- Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
- Psychiatric disorders or severe neurosis.
- Participation in other clinical experiments in recent 3 months;
- Any other conditions considered to be inappropriate to be involved in this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
The Army Medical University
Chongqing, Chongqing Municipality, 400037
Germany1 site
Thoraxklinik - Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg
About this study
Official title: The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions
The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.
Read the detailed description
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.
- Conditions
- Mediastinal Lymphadenopathy
- Being tested
- EBUS-TBMCB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBMCBProcedure or surgery
endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA-TBMCB | Experimental | endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) Receives: Procedure: EBUS-TBMCB |
| EBUS-TBNA | No intervention | endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic yield
percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
Measured: through study completion, an average of 1 year
prevalence of the procedure-related adverse events
the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
sample size
the area and diameter of sample obtained by each procedure
Measured: through study completion, an average of 1 year
consumed time
duration of each period in each procedure
Measured: through study completion, an average of 1 year
sample adequacy
the ratio of the number of patients with adequate sample by the procedure and the number of all the patients who have undergone this procedure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2022
- Study completion30 Apr 2022
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 Mediastinal LymphadenopathyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Principal investigator, Ye Fan, Third Military Medical University
- Investigators
- Ye Fan, PhD, Principal investigator, Third Military Medical UniversityFelix Herth, Principal investigator, Thoraxklinik - Heidelberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572984
- Sponsor's protocol ID
- EBUS-TBMCB 2020
- Status last verified
- Oct 2022
- First submitted
- 12 Sep 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22.
PubMed 36279880
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions
- ClinicalTrials.gov ID
- NCT04572984
- Acronym / sponsor ID
- EBUS-TBMCB 2020
- Conditions
- Mediastinal Lymphadenopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Oct 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.
The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.
Detailed description
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA-TBMCB | Experimental | Procedure: EBUS-TBMCBendobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) |
| EBUS-TBNA | No intervention | –endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=15 years;
- More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT;
- Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
- Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
- Informed consent form achievement.
Key exclusion criteria (7 listed)
- Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
- Failure to detect the mediastinal lesions in ultrasonic landscape;
- Cysts or abscess;
- Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
- Psychiatric disorders or severe neurosis.
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 |
|---|---|---|
| EBUS-TBMCBendobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA | Procedure or surgery | EBUS-TBNA-TBMCB |
Primary outcome
diagnostic yield
Time frame: through study completion, an average of 1 year
percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
prevalence of the procedure-related adverse events
Time frame: through study completion, an average of 1 year
the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm
3 secondary outcomes
sample size
Time frame: through study completion, an average of 1 year
consumed time
Time frame: through study completion, an average of 1 year
sample adequacy
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 36279880Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22.
- 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.
Ye Fan, PhD principal investigator
Third Military Medical University
Felix Herth principal investigator
Thoraxklinik - Heidelberg University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBMCB in people with Mediastinal Lymphadenopathy, run by Third Military Medical University at 2 sites in 2 countries.
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 7 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: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic yield (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT04572984, 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 13 Oct 2022.