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Mediastinal EBUS Cryobiopsy Study In Sweden

Recruitingn/aAges 18 Years - anyAllRegion Skane
NCT06347939 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pos

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • Mediastinal lymph nodes cryobiopsies
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Where

2 sites
Respiratory medicine and allergy department, Skåne University Hospital
Lund, Sweden
Norrlands universitetssjukhus
Umeå, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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