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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mediastinal lymph nodes cryobiopsies
Diagnostic testEBUS Mediastinal lymph nodes cryobiopsies
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: All the patients undergo the same procedure1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 yearsSecondary outcomes
1
Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer.
Material leading to a definite answer is considered adequate.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov