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RECRUITINGOBSERVATIONAL

Mediastinal EBUS Cryobiopsy Study In Sweden

Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Mediastinal lymph nodes cryobiopsies

EBUS Mediastinal lymph nodes cryobiopsies

Locations (2)

Respiratory medicine and allergy department, Skåne University Hospital
Lund, Sweden
Norrlands universitetssjukhus
Umeå, Sweden