Mediastinal EBUS Cryobiopsy Study In Sweden
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mediastinal lymph nodes cryobiopsies
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov