Actively Recruiting
Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
Led by Region Skane · Updated on 2025-07-17
200
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the added value and diagnostic yield of combining two methods, EBUS TBNA and EBUS TBMCB, for sampling mediastinal and hilar lymph nodes and masses. It focuses on patients with mediastinal lymphadenopathy, including conditions like lung cancer, sarcoidosis, lymphoma, and tuberculosis. The study is observational and non-randomized, comparing each participant's own samples to determine the number of biopsies needed for a definite diagnosis. All participants undergo both procedures during the same session. EBUS TBNA collects cytology specimens using a needle aspiration, while EBUS TBMCB obtains cryobiopsy samples for histopathological evaluation. The cryobiopsy samples are numbered to assess how many are needed for diagnosis and how much adding EBUS TBMCB improves diagnostic yield compared to EBUS TBNA alone. Participants will have a follow-up visit four weeks after the procedure to monitor for any postoperative complications. Researchers collect data on the number of biopsies taken, the diagnostic results, and the adequacy of samples for additional analysis, such as PDL1 testing in lung cancer. The study plans to include up to 200 cases, with data collected prospectively and systematically from two hospital sites.
CONDITIONS
Brief Title
Mediastinal EBUS Cryobiopsy Study In Sweden
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mediastinal lymphadenopathy with a diameter greater than 1 cm
- Indication for assessment and sampling according to clinical practice
- Age greater than 18 years
- Patients consent to participate in the study
You will not qualify if you...
- Hemodynamically unstable patient
- Myocardial infarction in the last six weeks prior to participating
- Life threatening arrhythmia
- Respiratory failure with inadequate oxygenation despite oxygen supply
- High-grade tracheal obstruction
- High bleeding risk
- Patient unwilling to participate
- Patient not speaking Swedish and needing a translator during the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo endobronchial ultrasound bronchoscopy procedures including transbronchial needle aspiration and cryobiopsies to obtain tissue samples for diagnosis.
1 procedure visit (in-person)
Duration - 4 weeks
Participants return for follow-up to assess the risk for postoperative complications after the procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
Respiratory medicine and allergy department, Skåne University Hospital
Lund, Sweden
Actively Recruiting
2
Norrlands universitetssjukhus
Umeå, Sweden
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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