Mediastinal LymphadenopathyMECRISNCT06347939
Mediastinal EBUS Cryobiopsy Study In Sweden
An observational study of Mediastinal Lymphadenopathy and Lung Cancer, run by Region Skane at 2 sites in Sweden.
Trial summary
This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy, Lung Cancer, Sarcoidosis
- What is being tested?
- Mediastinal lymph nodes cryobiopsies
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Apr 2024to 31 Dec 2028
- Phase
- Observational
- 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
Study population: Patients older than 18 years with mediastinal lymphadenopathy with a diameter greater than 1 cm who have indication to undergo sampling of lymph nodes for assessment according to clinical praxis.
Who may be able to join
- Mediastinal lymphadenopathy with a diameter greater than 1 cm.
- Indication for assessment and sampling according to clinical praxis
- Age > 18 years
- Patients consent to participate in the study.
Who cannot join
- Hemodynamically instable patient
- Myocardial infarction in the last six weeks prior to participating in the study.
- Life threatening arrythmia
- Respiratory failure and inadequate blood oxygenation despite oxygen supply.
- Tracheal obstruction of high grade.
- High bleeding risk
- Patient not willing to participate in the study
- Patient not speaking swedish and needing translator during the procedure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Respiratory medicine and allergy department, Skåne University Hospital
Lund
Hamid Akbarshahi, MD, PhD, 004646171000, hamid.akbarshahi@med.lu.se
- Recruiting
Norrlands universitetssjukhus
Umeå
Annelie Behndig, MD, PhD, 0907850000, annelie.behndig@umu.se
About this study
Official title: Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).
Follow up four weeks after the procedure to assess the risk for postoperative complications.
Read the detailed description
Endobronchial ultrasound bronchoscopy (EBUS) is an established method for sampling of mediastinal and hilar lymph nodes and masses. Cytology specimens can be obtained with transbronchial needle aspiration (EBUS TBNA), and this is a valuable tool in the diagnostic work up of lesions adjacent to central airways and in the staging of lung cancer. EBUS TBNA is a robust method that shows excellent results in diagnosing lung cancer cases with a reported diagnostic yield up to 90% from multiple studies. EBUS TBNA is a safe procedure with reported complications in 1,2 - 3,6% of cases.
In clinical situations where non-malignant diseases (e.g. sarcoidosis, tuberculosis) or malignancies other than lung cancer (e.g. lymphoma) affect the mediastinum is the efficacy of EBUS TBNA relatively limited and these cases often require histopathological evaluation rather than cytological assessment.
EBUS TBMCB (EndoBronchial UltraSound TransBronchial Mediastinal CryoBiopsy) is a novel method of obtaining cryobiopsies for histopathology from mediastinal lesions, which has previously not been possible with endobronchial procedures. This method is becoming more utilised internationally after the publication of the first studies examining its safety and efficacy. In the last couple of years has EBUS TBMCB been evaluated in two randomized studies from the same study group and a few observational studies where adding EBUS TBMCB to EBUS TBNA showed an increase in diagnostic yield without adding significant adverse events. The sensitivity of EBUS TBMCB were similar to that of EBUS TBNA in cases of lung cancer but there was found, in all studies, a significant increase of diagnostic yield in cases of non-malignant diseases and metastases from extra thoracic tumours.
There are however some aspects of this novel method yet not studied like the number of biopsies needed from a lesion to collect adequate material for histopathological evaluation. At the thoracic oncology diagnostics units at Skåne University Hospital and Umeå University hospital, EBUS TBMCB has been introduced in clinical practice, performed by experienced bronchoscopists. In recognition of the need for further clarification regarding several aspects of this novel method the investigators plan to collect data prospectively and systematically from EBUS TBMCB procedures.
Our study is a prospective observational non-randomized clinical trial where all the patients undergo the same procedure and every patient's own samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB to all the study participants and the investigators are numbering the cryobiopsy samples to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same patient. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).
Follow up four weeks after the procedure to assess the risk for postoperative complications.
Data will be collected in both sites from all EBUS TBMCB procedures eligible according to inclusion criteria, where patients agree to partake in the study, until 200 cases are reached.
- Conditions
- Mediastinal Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma, Tuberculosis
- Being tested
- Mediastinal lymph nodes cryobiopsies
- Keywords
- Mediastinal lymphadenopathy, Lung cancer, Sarcoidosis, Tuberculosis, Lymphoma
- Medical subject headings
- Lung Neoplasms, Sarcoidosis, Lymphoma, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediastinal lymph nodes cryobiopsiesDiagnostic test
Also called Mediastinal lymph nodes fine needle aspiration
EBUS Mediastinal lymph nodes cryobiopsies
| Study group | Role | What they receive |
|---|---|---|
| All the patients undergo the same procedure | All the patients undergo the same procedure and every patient's own samples are compared to each other. Receives: Diagnostic Test: Mediastinal lymph nodes cryobiopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis.
The result will be presented as the mean value of the number of biopsies needed to analyze for each individual to reach a definite diagnosis.
Measured: 2 years
Secondary outcomes (1)
Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer.
Material leading to a definite answer is considered adequate.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Akbarshahi, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347939
- Sponsor's protocol ID
- 2023-06638-01
- Other IDs
- 2023
- Acronym
- MECRIS
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2024
- Last updated
- 17 Jul 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
- ClinicalTrials.gov ID
- NCT06347939
- Acronym / sponsor ID
- MECRIS / 2023-06638-01
- Conditions
- Mediastinal Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma, Tuberculosis
- Keywords
- Mediastinal lymphadenopathy, Lung cancer, Sarcoidosis, Tuberculosis, Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Apr 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.
This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).
Follow up four weeks after the procedure to assess the risk for postoperative complications.
Detailed description
Endobronchial ultrasound bronchoscopy (EBUS) is an established method for sampling of mediastinal and hilar lymph nodes and masses. Cytology specimens can be obtained with transbronchial needle aspiration (EBUS TBNA), and this is a valuable tool in the diagnostic work up of lesions adjacent to central airways and in the staging of lung cancer. EBUS TBNA is a robust method that shows excellent results in diagnosing lung cancer cases with a reported diagnostic yield up to 90% from multiple studies. EBUS TBNA is a safe procedure with reported complications in 1,2 - 3,6% of cases.
In clinical situations where non-malignant diseases (e.g. sarcoidosis, tuberculosis) or malignancies other than lung cancer (e.g. lymphoma) affect the mediastinum is the efficacy of EBUS TBNA relatively limited and these cases often require histopathological evaluation rather than cytological assessment.
EBUS TBMCB (EndoBronchial UltraSound TransBronchial Mediastinal CryoBiopsy) is a novel method of obtaining cryobiopsies for histopathology from mediastinal lesions, which has previously not been possible with endobronchial procedures. This method is becoming more utilised internationally after the publication of the first studies examining its safety and efficacy. In the last couple of years has EBUS TBMCB been evaluated in two randomized studies from the same study group and a few observational studies where adding EBUS TBMCB to EBUS TBNA showed an increase in diagnostic yield without adding significant adverse events. The sensitivity of EBUS TBMCB were similar to that of EBUS TBNA in cases of lung cancer but there was found, in all studies, a significant increase of diagnostic yield in cases of non-malignant diseases and metastases from extra thoracic tumours.
There are however some aspects of this novel method yet not studied like the number of biopsies needed from a lesion to collect adequate material for histopathological evaluation. At the thoracic oncology diagnostics units at Skåne University Hospital and Umeå University hospital, EBUS TBMCB has been introduced in clinical practice, performed by experienced bronchoscopists. In recognition of the need for further clarification regarding several aspects of this novel method the investigators plan to collect data prospectively and systematically from EBUS TBMCB procedures.
Our study is a prospective observational non-randomized clinical trial where all the patients undergo the same procedure and every patient's own samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB to all the study participants and the investigators are numbering the cryobiopsy samples to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same patient. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).
Follow up four weeks after the procedure to assess the risk for postoperative complications.
Data will be collected in both sites from all EBUS TBMCB procedures eligible according to inclusion criteria, where patients agree to partake in the study, until 200 cases are reached.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the patients undergo the same procedure | – | Diagnostic Test: Mediastinal lymph nodes cryobiopsiesAll the patients undergo the same procedure and every patient's own samples are compared to each other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years with mediastinal lymphadenopathy with a diameter greater than 1 cm who have indication to undergo sampling of lymph nodes for assessment according to clinical praxis.
Key inclusion criteria (4 listed)
- Mediastinal lymphadenopathy with a diameter greater than 1 cm.
- Indication for assessment and sampling according to clinical praxis
- Age > 18 years
- Patients consent to participate in the study.
Key exclusion criteria (8 listed)
- Hemodynamically instable patient
- Myocardial infarction in the last six weeks prior to participating in the study.
- Life threatening arrythmia
- Respiratory failure and inadequate blood oxygenation despite oxygen supply.
- Tracheal obstruction of high grade.
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 |
|---|---|---|
| Mediastinal lymph nodes cryobiopsiesAlso: Mediastinal lymph nodes fine needle aspirationEBUS Mediastinal lymph nodes cryobiopsies | Diagnostic test | All the patients undergo the same procedure |
Primary outcome
Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis.
Time frame: 2 years
The result will be presented as the mean value of the number of biopsies needed to analyze for each individual to reach a definite diagnosis.
1 secondary outcome
Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer.
Time frame: 2 years
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 17 Jul 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.
Respiratory medicine and allergy department, Skåne University Hospital
Lund, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Lymphadenopathy and Lung Cancer, run by Region Skane at 2 sites in Sweden.
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 8 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 17 Jul 2025. 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 Sweden. 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?
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?
Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis. (time frame: 2 years). 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 17 Jul 2025.