Mediastinal LymphadenopathyNCT06741852
Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided- Transbronchial Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy
A study testing nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel and Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel in people with Mediastinal Lymphadenopathy, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Mediastinal and/or hilar lymphadenopathy (MHL) becoming more and more common in clinical practice with the development of imaging technique. MHL is secondary to various benign and malignant disorders that could be life-threatening conditions due to compression of airways or blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy
- What is being tested?
- nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel and Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 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
- (1) Age ≥18 years old; (2) Patients with at least one mediastinal and/or hilar lymphadenopathy (short-axis ≥1cm that is detected by chest CT or contrast CT; (3) Patients with recently discovered mediastinal lesions, clinical respiratory symptoms of cough, expectoration, thoracalgia, or complicated lung lesions implicated by thoracic image, which indicates the need of biopsy to identify the etiology; (4) Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Who cannot join
- (1) The lesion is a mediastinal cyst or abscess; (2) Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy; (3) EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy; (4) EBUS did not detect lesions in the hilum and/or mediastinum; (5) Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
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
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Gang Hou, M.D., PhD., 010-84205729, hougangcmu@163.com
About this study
Official title: The Diagnostic Yield and Safety of Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy: a Multi-center Randomized Controlled Trial.
Mediastinal and/or hilar lymphadenopathy (MHL) becoming more and more common in clinical practice with the development of imaging technique. MHL is secondary to various benign and malignant disorders that could be life-threatening conditions due to compression of airways or blood vessels. Accurate and timely diagnosis is important for managing patients with lymphadenopathy. Nowadays, several invasive mediastinal tissue samplings have been designed and development.
For patients with metastatic lymphadenopathy, endobronchial ultrasound (EBUS) guided transbronchial needle aspiration has been recommended as a first-line diagnostic method by several guidelines due to its highly diagnostic sensitivity for non-small cell lung cancer and acceptable safety.However, the relatively limited material retrieved by needle aspiration restricts its diagnostic yield in non-metastatic lymphadenopathy including sarcoidosis, lymphoma, tuberculosis, etc.6,7 It is important to obtain the representative sample which showed the specific pathology for diagnosing patients with non-metastatic lymphadenopathy. Therefore, previous studies attempt to use transbronchial mediastinal cryobiopsy (TBMC) to obtain acquiring samples with sufficient volume suitable for histological and molecular analyses.
Read more
Despite several studies have proved that TBMC has a highly diagnostic yield, the heterogeneity of pathologic characteristics in lymph node makes obtaining a representative sample difficult. To overcome the sampling heterogeneity and obtain the possibility of obtaining a representative sample in mediastinal lesions, increasing sampling number had been proved as an effective method in previous studies (5-times TBNA, thrice TBMC). With the increasing sampling number, the potential risk related to the procedure is higher than before.
Needle-based confocal laser endomicroscopy (nCLE) is a laser-based imaging technique that utilizes fluorescence for real-time microscopic imaging at the biopsy needle tip. Compared to EBUS, nCLE enables real-time visualisation of cell shapes, there by acting a real-time microscope. Besides, we had developed a novel procedure which can built a tunnel between airway wall and target lymph node using a puncture dilation catheter and allows various tools to perform procedure, its efficacy and safety had been proved in our published studies.Based on this tunnel, we could perform TBMC under the nCLE guidance. The area with representative pathology of lymph node may be detected by nCLE, and shorten the sampling number. However, it remains unknown which of these techniques is the superior match for needle biopsy.
- Conditions
- Mediastinal Lymphadenopathy
- Being tested
- nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel, Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnelProcedure or surgery
Patients received 2.5mL of 10% Fluorescite intravenously during nCLE. The CLE probe was preloaded into a puncture dilation catheter and locked into position with 2mm being exposed beyond the tip. puncture dilation catheter. The lymph node was punctured and the needle positioned at its center. The probe was advanced and locked, and the needle was advanced to the contralateral edge of the lymph node. Image acquisition began at the lymph node capsule, and then the subcapsular region, followed by the cortical sinus. When the image showed granuloma or malignant characteristics, the location will be recorded in EBUS, and retract the CLE probe, leaving the sheath of puncture dilation catheter as a tunnel between airway wall and target lymph node. Then, a 1.1-mm cryoprobe was inserted into the target lymph node through this tunnel under the EBUS guidance. The probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue.
Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnelProcedure or surgery
First a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Broncus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of target lymph node was measured using EBUS. After confirming that the distance was >5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times.
| Study group | Role | What they receive |
|---|---|---|
| nCLE-TBMC via a tunnel | Experimental | Participants will receive nCLE-TBMC to obtain the samples from mediastinal lesions. Receives: Procedure: nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel |
| TBMC via a tunnel | Experimental | Participates will receive TBMC via a tunnel to obtain the samples from mediastinal lesions. Receives: Procedure: Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The diagnostic yield was defined as the percentage of biopsy results that matched the final diagnosis.
Measured: 14 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mediastinal LymphadenopathyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 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
- NCT06741852
- Sponsor's protocol ID
- 2024-CLE-LYM
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kramer T, Wijsman PC, Kalverda KA, Bonta PI, Annema JT. Advances in bronchoscopic optical coherence tomography and confocal laser endomicroscopy in pulmonary diseases. Curr Opin Pulm Med. 2023 Jan 1;29(1):11-20. doi: 10.1097/MCP.0000000000000929. Epub 2022 Nov 16.
PubMed 36474462Tournoy TK, Tournoy KG. Digging mediastinal holes with vigour: a word of caution. Eur Respir J. 2021 Dec 31;59(1):2101381. doi: 10.1183/13993003.01381-2021. Print 2022 Jan. No abstract available.
PubMed 34140295Sun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12.
PubMed 25497069Poletti V, Petrarulo S, Piciucchi S, Dubini A, De Grauw AJ, Sultani F, Martinello S, Gonunguntla HK, Ravaglia C. EBUS-guided cryobiopsy in the diagnosis of thoracic disorders. Pulmonology. 2024 Sep-Oct;30(5):459-465. doi: 10.1016/j.pulmoe.2023.11.008. Epub 2024 Jan 5.
PubMed 38182468Zhang J, Guo JR, Huang ZS, Fu WL, Wu XL, Wu N, Kuebler WM, Herth FJF, Fan Y. Transbronchial mediastinal cryobiopsy in the diagnosis of mediastinal lesions: a randomised trial. Eur Respir J. 2021 Dec 9;58(6):2100055. doi: 10.1183/13993003.00055-2021. Print 2021 Dec.
PubMed 33958432
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Yield and Safety of Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy: a Multi-center Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06741852
- Acronym / sponsor ID
- 2024-CLE-LYM
- Conditions
- Mediastinal Lymphadenopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Dec 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.
Mediastinal and/or hilar lymphadenopathy (MHL) becoming more and more common in clinical practice with the development of imaging technique. MHL is secondary to various benign and malignant disorders that could be life-threatening conditions due to compression of airways or blood vessels. Accurate and timely diagnosis is important for managing patients with lymphadenopathy. Nowadays, several invasive mediastinal tissue samplings have been designed and development.
For patients with metastatic lymphadenopathy, endobronchial ultrasound (EBUS) guided transbronchial needle aspiration has been recommended as a first-line diagnostic method by several guidelines due to its highly diagnostic sensitivity for non-small cell lung cancer and acceptable safety.However, the relatively limited material retrieved by needle aspiration restricts its diagnostic yield in non-metastatic lymphadenopathy including sarcoidosis, lymphoma, tuberculosis, etc.6,7 It is important to obtain the representative sample which showed the specific pathology for diagnosing patients with non-metastatic lymphadenopathy. Therefore, previous studies attempt to use transbronchial mediastinal cryobiopsy (TBMC) to obtain acquiring samples with sufficient volume suitable for histological and molecular analyses.
Despite several studies have proved that TBMC has a highly diagnostic yield, the heterogeneity of pathologic characteristics in lymph node makes obtaining a representative sample difficult. To overcome the sampling heterogeneity and obtain the possibility of obtaining a representative sample in mediastinal lesions, increasing sampling number had been proved as an effective method in previous studies (5-times TBNA, thrice TBMC). With the increasing sampling number, the potential risk related to the procedure is higher than before.
Needle-based confocal laser endomicroscopy (nCLE) is a laser-based imaging technique that utilizes fluorescence for real-time microscopic imaging at the biopsy needle tip. Compared to EBUS, nCLE enables real-time visualisation of cell shapes, there by acting a real-time microscope. Besides, we had developed a novel procedure which can built a tunnel between airway wall and target lymph node using a puncture dilation catheter and allows various tools to perform procedure, its efficacy and safety had been proved in our published studies.Based on this tunnel, we could perform TBMC under the nCLE guidance. The area with representative pathology of lymph node may be detected by nCLE, and shorten the sampling number. However, it remains unknown which of these techniques is the superior match for needle biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nCLE-TBMC via a tunnel | Experimental | Procedure: nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnelParticipants will receive nCLE-TBMC to obtain the samples from mediastinal lesions. |
| TBMC via a tunnel | Experimental | Procedure: Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnelParticipates will receive TBMC via a tunnel to obtain the samples from mediastinal lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Age ≥18 years old; (2) Patients with at least one mediastinal and/or hilar lymphadenopathy (short-axis ≥1cm that is detected by chest CT or contrast CT; (3) Patients with recently discovered mediastinal lesions, clinical respiratory symptoms of cough, expectoration, thoracalgia, or complicated lung lesions implicated by thoracic image, which indicates the need of biopsy to identify the etiology; (4) Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Key exclusion criteria (1 listed)
- (1) The lesion is a mediastinal cyst or abscess; (2) Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy; (3) EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy; (4) EBUS did not detect lesions in the hilum and/or mediastinum; (5) Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
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 |
|---|---|---|
| nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnelPatients received 2.5mL of 10% Fluorescite intravenously during nCLE. The CLE probe was preloaded into a puncture dilation catheter and locked into position with 2mm being exposed beyond the tip. puncture dilation catheter. The lymph node was punctured and the needle positioned at its center. The probe was advanced and locked, and the needle was advanced to the contralateral edge of the lymph node. Image acquisition began at the lymph node capsule, and then the subcapsular region, followed by the cortical sinus. When the image showed granuloma or malignant characteristics, the location will be recorded in EBUS, and retract the CLE probe, leaving the sheath of puncture dilation catheter as a tunnel between airway wall and target lymph node. Then, a 1.1-mm cryoprobe was inserted into the target lymph node through this tunnel under the EBUS guidance. The probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue. | Procedure or surgery | nCLE-TBMC via a tunnel |
| Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnelFirst a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Broncus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of target lymph node was measured using EBUS. After confirming that the distance was >5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times. | Procedure or surgery | TBMC via a tunnel |
Primary outcome
Diagnostic yield
Time frame: 14 days post-procedure
The diagnostic yield was defined as the percentage of biopsy results that matched the final diagnosis.
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 19 Dec 2024.
- Results publication: PubMed 36474462Kramer T, Wijsman PC, Kalverda KA, Bonta PI, Annema JT. Advances in bronchoscopic optical coherence tomography and confocal laser endomicroscopy in pulmonary diseases. Curr Opin Pulm Med. 2023 Jan 1;29(1):11-20. doi: 10.1097/MCP.0000000000000929. Epub 2022 Nov 16.
- Results publication: PubMed 34140295Tournoy TK, Tournoy KG. Digging mediastinal holes with vigour: a word of caution. Eur Respir J. 2021 Dec 31;59(1):2101381. doi: 10.1183/13993003.01381-2021. Print 2022 Jan. No abstract available.
- Results publication: PubMed 25497069Sun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12.
- Results publication: PubMed 38182468Poletti V, Petrarulo S, Piciucchi S, Dubini A, De Grauw AJ, Sultani F, Martinello S, Gonunguntla HK, Ravaglia C. EBUS-guided cryobiopsy in the diagnosis of thoracic disorders. Pulmonology. 2024 Sep-Oct;30(5):459-465. doi: 10.1016/j.pulmoe.2023.11.008. Epub 2024 Jan 5.
- Results publication: PubMed 33958432Zhang J, Guo JR, Huang ZS, Fu WL, Wu XL, Wu N, Kuebler WM, Herth FJF, Fan Y. Transbronchial mediastinal cryobiopsy in the diagnosis of mediastinal lesions: a randomised trial. Eur Respir J. 2021 Dec 9;58(6):2100055. doi: 10.1183/13993003.00055-2021. Print 2021 Dec.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel and Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel in people with Mediastinal Lymphadenopathy, 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: opening soon, as of the sponsor's last update on 19 Dec 2024. 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, M.D., PhD. (+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?
Diagnostic yield (time frame: 14 days post-procedure). 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 NCT06741852, which also lists 5 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 19 Dec 2024.